Hồ sơ đã công bố

CÔNG TY TNHH DƯỢC PHẨM HOÀN NGUYÊN

---------------------------

Số 02.2021/AP-SYT

Cộng hòa Xã hội Chủ nghĩa Việt Nam

Độc lập - Tự do - Hạnh phúc

---------------------------

Thành phố Hà Nội , ngày 23 tháng 03 năm 2021

VĂN BẢN CÔNG BỐ
Đủ điều kiện mua bán trang thiết bị y tế
Kính gửi: Sở Y tế Hà Nội

1. Tên cơ sở: CÔNG TY TNHH DƯỢC PHẨM HOÀN NGUYÊN

Mã số thuế: 0101379909

Địa chỉ: C3, Dự án PANDORA, số 53 phố Triều Khúc, Phường Thanh Xuân Nam, Quận Thanh Xuân, Thành phố Hà Nội

Văn phòng giao dịch(nếu có): - , , ,

2. Người đại diện hợp pháp của cơ sở:

Họ và tên: Đặng Ngọc Định

Số CMND/Định danh/Hộ chiếu: 010424045   ngày cấp: 04/10/2008   nơi cấp: CA Hà Nội

Điện thoại cố định: 0903200796   Điện thoại di động:

3. Cán bộ kỹ thuật của cơ sở mua bán:

Họ và tên: Đặng Ngọc Định

Số CMND/Định danh/Hộ chiếu: 010424045   ngày cấp: 04/10/2008   nơi cấp: CA Hà Nội

Trình độ chuyên môn: Đại học

4. Danh mục trang thiết bị y tế do cơ sở thực hiện mua bán:

STTTên trang thiết bị y tế
1Bóng nong động mạch chủ
2Dụng cụ dẫn đường và cầm máu động mạch chủ
3Khung giá đỡ động mạch vành loại Zotarolimus
4Khung giá đỡ động mạch vành loại thường
5Bóng nong động mạch vành
6Catheter trợ giúp can thiệp tim mạch
7Bộ dụng cụ hút huyết khối động mạch vành
8Dụng cụ mở đường vào động mạch đùi
9Bơm áp lực cao sử dụng trong kỹ thuật can thiệp tim mạch
10Dây dẫn đường cho Catheter
11Catheter chụp động mạch vành
12Bộ van dẫn lưu não thất ổ bụng
13Van dẫn lưu não thất ổ bụng
14Ống thông não thất
15Ống thông màng bụng tim
16Que luồn dưới da
17Lưới vá sọ Titan
18Đinh vit Titan
19Nẹp Titan
20Miếng vá, tái tạo màng cứng
21Nẹp ghim cố định xương sọ
22Bộ dẫn lưu não ngoài
23Băng dán vết thương (DuoDERM Extra thin 5x10cm)
24Băng dán vết thương (DuoDERM Extra thin 10x10cm)
25Băng dán vết thương (DuoDERM Extra thin 5x20cm)
26Băng dán vết thương (DuoDERM CGF 10x10cm)
27Băng dán vết thương (DuoDERM CGF 20x20cm)
28Gel Hydrocolloid dành cho vết thương (DuoDERM Hydroactive Gel 15G)
29Gel Hydrocolloid dành cho vết thương (DuoDERM Hydroactive Gel 30G)
30Gạc vết thương (AQUACEL Extra 10x10cm)
31Gạc vết thương (AQUACEL Ag Extra 10x10cm)
32Gạc vết thương (AQUACEL Ag 2x45cm)
33Gạc vết thương (AQUACEL Ag Extra 20x30cm)
34Gạc vết thương (AQUACEL Ag+ Extra 10x10cm)
35Gạc vết thương (AQUACEL Ag+ 2x45cm)
36Băng dán vết thương (AQUACEL Foam 10x10cm)
37Băng dán vết thương (AQUACEL Foam 20x20cm)
38Băng dán vết thương (AQUACEL Foam 12,5x12,5cm)
39Băng dán vết thương (AQUACEL Foam 17,5x17,5cm)
40Băng dán vết thương (AQUACEL Ag Foam 12,5x12,5cm)
41Băng dán vết thương (AQUACEL Ag Foam 17,5x17,5cm)
42Băng dán vết thương (AQUACEL Surgical 9x15cm)
43Băng dán vết thương (AQUACEL Surgical 9x25cm)
44Bộ dụng cụ thông hậu môn (FLEXI-SEAL SIGNAL FMS Kit)
45Túi chứa phân, dùng kèm bộ dụng cụ thông hậu môn (FLEXI-SEAL FMS Collection Bag)
46Phổi nhân tạo từ 10 - 20kg
47Dây dẫn dùng cho phổi nhân tạo hàng cân từ 10-20kg
48Dây dẫn dùng cho phổi nhân tạo hàng cân trên 50kg
49Van tim cơ học nhân tạo
50Vòng van tim nhân tạo
51Ống nối ca-nuyn các loại
52Ống thông giãn nở mạch vành
53Ống thông hút huyết khối
54Thiết bị bơm khí tạo hình bóng nong
55Ống thông vi mô mạch vành
56Ống thông dẫn thuốc cản quang dùng trong chụp mạch
57Ống thông mở rộng trợ giúp can thiệp
58Direct BILIRUBIN
59Direct LDL
60ICT Serum Calibrator
61ICT Urine Calibrator
62Multiconstituent Calibrator
63Bilirubin Calibrator
64Specific Proteins Multiconstituent Calibrator
65Cystatin C
66Cystatin C Calibrator
67Cystatin C Control Set
68LACTATE DEHYDROGENASE
69LIPASE Calibrator
70Ultra HDL
71CALCIUM
72CREATININE
73Glucose
74URIC ACID
75MAGNESIUM
76Multichem S Plus (Assayed)
77Multichem P
78TDM Multiconstituent Calibrator
79Vancomycin
80CK-MB Calibrator
81CK-MB Control
82CK-MB
83CRP Calibrator WR
84CRP Calibrator HS
85CRP Vario
86Quantia β2-Microglobulin
87Quantia RF
88Quantia β2-Microglobulin Standard
89Quantia RF Standard
90Ammonia Ultra
91Ammonia Controls
92Iron
93Total BILIRUBIN
94ALBUMIN BCG
95ALKALINE PHOSPHATASE
96AMYLASE
97CHOLESTEROL
98GAMMA-GLUTAMYL TRANSFERASE
99PHOSPHORUS
100TOTAL PROTEIN
101TRIGLYCERIDE
102UREA NITROGEN
103Urine/CSF Protein
104LIPASE
105CRP Calibrator set
106Activated Aspartate Aminotransferase
107ACTIVATED ALANINE AMINOTRANSFERASE
108Lipid Multiconstituent Calibrator
109CREATINE KINASE
110ARCHITECT CA 15-3 Controls
111ARCHITECT CA 125 II Controls
112ARCHITECT CA 19- 9XR Controls
113Architect PIVKA II Calibrators
114Architect PIVKA II Controls
115ARCHITECT PIVKA-II Reagent Kit (1x100 tests)
116ARCHITECT Homocysteine Calibrators
117Architect Homocysteine Controls
118ARCHITECT Homocysteine Reagent Kit
119ARCHITECT Cyclosporine Calibrators
120ARCHITECT Cyclosporine (Reagent kit)
121ARCHITECT CYCLOSPORINE Whole Blood Precipitation Reagent Kit
122ARCHITECT Tacrolimus Calibrators
123ARCHITECT TACROLIMUS Reagent kit
124ARCHITECT TACROLIMUS Whole Blood Precipitation Reagent
125ARCHITECT i Vancomycin Calibrators
126ARCHITECT iVancomycin Reagent Kit
127ARCHITECT ProGRP Calibrators
128ARCHITECT ProGRP Controls
129ARCHITECT ProGRP Reagent Kit
130Architect Anti-CCP Calibrators
131ARCHITECT Anti-CCP Controls
132ARCHITECT Anti-CCP Reagent Kit (1 x 100 Tests)
133Architect Folate Calibrators
134ARCHITECT Folate Controls
135ARCHITECT Folate Reagent Kit
136ARCHITECT CA 15-3 Calibrators
137ARCHITECT CA 15-3 Reagent Kit
138Architect CA 125 II Calibrators
139ARCHITECT CA 125 II Reagent Kit
140ARCHITECT Anti- Tg Calibrators
141ARC.Anti TG Controls
142ARC.Anti-TG Reagent kit
143ARCHITECT Thyroglobulin Calibrator
144ARCHITECT Thyroglobulin Controls
145ARCHITECT Thyroglobulin Reagent Kit
146Architect CA19-9XR Calibrators
147ARCHITECT CA 19-9XR Reagent Kit
148Architect 2nd Generation Testosterone Calibrators
149Architect 2nd Generation Testosterone Reagent Kit
150Architect LH Calibrators
151ARCHITECT LH Reagent Kit
152ARCHITECT HE4 Calibrators
153ARCHITECT HE4 Controls
154ARCHITECT HE4 Reagent Kit
155ARCHITECT CYFRA 21-1 Calibrators
156Architect CYFRA 21-1 Controls
157ARCHITECT CYFRA 21-1 Reagent Kit
158ARCHITECT 25-OH Vitamin D Calibrator Kit
159ARCHITECT 25-OH Vitamin D Controls
160ARCHITECT 25-OH Vitamin D Reagent Kit
161Architect STAT High Sensitive Troponin-I Calibrators
162Architect STAT High Sensitive Troponin-I Reagent kit
163Architect AFP Calibrators
164ARCHITECT AFP Reagent kit
165Multichem WBT
166Multichem IA Plus
167ARCHITECT Ferritin Reagent Kit
168ARCHITECT B12 Calibrators
169ARCHITECT B12 Controls
170ARCHITECT B12 Reagent Kit
171Architect TSH Calibrators
172ARCHITECT TSH Reagent Kit
173ARCHITECT Free T3 Calibrators
174ARCHITECT Free T3 Reagent Kit
175Architect Total T3 Calibrators
176ARCHITECT Total T3 Reagent Kit
177ARCHITECT Free T4 Calibrators
178ARCHITECT Free T4 Reagent kit
179ARCHITECT CEA Calibrators
180Architect CEA Reagent kit
181ARCHITECT Total PSA Calibrators
182Architect Total PSA Reagent Kit
183ARCHITECT Free PSA Calibrators
184ARCHITECT Fres PSA Reagent
185ARCHITECT Estradiol Calibrators
186ARCHITECT Estradiol Reagent Kit
187ARCHITECT FSH Calibrators
188Architect FSH Reagent Kit
189ARCHITECT Prolactin Calibrators
190ARCHITECT Prolactin Reagent Kit
191ARCHITECT Progesterone Calibrators
192ARCHITECT Progesterone Reagent Kit
193ARCHITECT Total β-hCG Calibrators
194Architect Total β-hCG Reagent Kit
195ARCHITECT Pepsinogen I Calibrators
196Architect Pepsinogen I Controls
197ARCHITECT Pepsinogen I Reagent Kit
198ARCHITECT Cortisol Calibrators
199ARCHITECT Cortisol Reagent Kit
200ARCHITECT C-SCC Calibrators
201ARCHITECT SCC Controls
202ARCHITECT SCC Reagent Kit (100 Tests)
203ARCHITECT Intact PTH Calibrators
204ARCHITECT Intact PTH Controls
205ARCHITECT Intact PTH Reagent Kit (1x100 Tests)
206ARCHITECT Insulin Calibrators
207ARCHITECT Insulin (reagent kit)
208ARCHITECT Pepsinogen II Calibrators
209Architect Pepsinogen II Controls
210ARCHITECT Pepsinogen II Reagent Kit
211Architect B.R.A.H.M.S PCT Calibrators
212Architect B.R.A.H.M.S PCT Controls
213Architect B.R.A.H.M.S PCT Reagent Kit (1x100)
214ARCHITECT Ferritin Calibrators
215ARCHITECT Total T4 Calibrators
216ARCHITECT Total T4 Reagent Kit
217Alinity Trigger Solution
218Alinity i-series Probe Conditioning Solution
219Alinity Pre-Trigger Solution
220Alinity i-series Concentrated Wash Buffer
221Alinity c Albumin BCG Reagent Kit
222Alinity c Albumin BCP Reagent Kit
223Alinity c Alkaline Phosphatase Reagent Kit
224Alinity c Alanine Aminotransferase Reagent Kit
225Alinity c Activated Alanine Aminotransferase Reagent Kit
226Alinity c Ammonia Ultra Reagent Kit
227Alinity c Ammonia Control
228Alinity c Amylase Reagent Kit
229Alinity c Aspartate Aminotransferase Reagent Kit
230Alinity c Activated Asparate Aminotransferase Reagent Kit
231Alinity c Direct Bilirubin Reagent Kit
232Alinity c Total Bilirubin Reagent Kit
233Alinity c Calcium Reagent Kit
234Alinity c Cholesterol Reagent Kit
235Alinity c Creatine Kinase Reagent Kit
236Alinity c Creatinine Reagent Kit
237Alinity c Digoxin Reagent Kit
238Alinity c Glucose Reagent Kit
239Alinity c CRP Vario Reagent Kit
240Alinity c CRP Vario Wide Range Calibrator Kit
241Alinity c CRP Vario High Sensitivity Calibrator Kit
242Alinity c CRP Vario HS Control Kit
243Alinity c Iron Reagent Kit
244Alinity c Lactate Dehydrogenase Reagent Kit
245Alinity c Lactic Acid Reagent Kit
246Alinity c Direct LDL Reagent Kit
247Alinity c Magnesium Reagent Kit
248Alinity c Microalbumin Reagent Kit
249Alinity c Microalbumin Calibrators
250Alinity c Phosphorus Reagent Kit
251Alinity c Total Protein Reagent Kit
252Alinity c Triglyceride Reagent Kit
253Alinity c Ultra HDL Reagent Kit
254Alinity c Urea Nitrogen Reagent Kit
255Alinity c Uric Acid Reagent Kit
256Alinity c Urine/CSF Protein Reagent Kit
257Alinity c Vancomycin Reagent Kit
258Alinity c Creatinine (Enzymatic) Reagent Kit
259Alinity c Gamma-Glutamyl Transferase Reagent Kit
260Alinity c Lactate Dehydrogenase Reagent Kit
261Alinity c Microalbumin Controls
262Alinity c UIBC Reagent Kit
263Alinity c UIBC Calibrator Kit
264Alinity c Ultra HDL Reagent Kit
265Alinity c Uric Acid Reagent Kit
266Alinity c Clinical Chemistry Calibrator Kit
267Alinity c Clinical Chemistry Control 1 Kit
268Alinity c Clinical Chemistry Control 2 Kit
269Alinity c TDM Multiconstituent Calibrator Kit
270Alinity c ICT Serum Calibrator Kit
271Alinity c ICT Urine Calibrator Kit
272Alinity c Immuno Control 1 Kit
273Alinity c Immuno Control 2 Kit
274Alinity c Immuno Control Set
275Alinity c Urine/CSF Protein Calibrator Kit
276Multichem P
277Multichem S Plus Assayed
278Multichem S Plus Unassayed
279Multichem U
280Alinity c ASO Reagent Kit
281Alinity c ASO Standard
282Alinity c ASO-RF Control I Kit
283Alinity c ASO-RF Control II Kit
284Alinity c CK-MB Calibrator Kit
285Alinity c CK-MB Control Kit
286Alinity c CK-MB Reagent Kit
287Alinity c Complement C3 Reagent Kit
288Alinity c Complement C4 Reagent Kit
289Alinity c Amikacin Reagent Kit
290Alinity c PROTEINS Calibrators
291Alinity c PROTEINS Controls Kit
292Alinity c-series Acid Wash
293Alinity c-series Alkaline Wash
294Alinity c-series Acid Probe Wash
295ALINITY i AFP Reagent Kit
296ALINITY i AFP Calibrators
297ALINITY i AFP Controls
298Alinity i B12 Reagent Kit
299Alinity i B12 Calibrators
300Alinity i B12 Controls
301ALINITY i Total β-hCG Reagent Kit
302ALINITY i Total β-hCG Calibrators
303ALINITY i Total β-hCG Controls
304ALINITY i BNP Reagent Kit (2 x 100 Tests)
305ALINITY i BNP Calibrators
306ALINITY i BNP Controls
307ALINITY i CA 125 II Reagent Kit (2 x 100 Tests)
308ALINITY i CA 125 II Calibrators
309ALINITY i CA 125 II Controls
310ALINITY i CA 15-3 Reagent Kit (2 x 100 Tests)
311ALINITY i CA 15-3 Calibrators
312ALINITY i CA 15-3 Controls
313ALINITY i CA 19-9XR Reagent Kit (2 x 100 Tests)
314ALINITY i CA 19-9XR Calibrators
315ALINITY i CA 19-9XR Controls
316ALINITY i CEA Reagent Kit
317ALINITY i CEA Calibrators
318ALINITY i CEA Controls
319ALINITY i Cortisol Reagent Kit
320ALINITY i Cortisol Calibrators
321Alinity i Estradiol Reagent Kit
322Alinity i Estradiol Manual Diluent
323Alinity i Estradiol Calibrators
324Alinity i Estradiol Controls
325ALINITY i Ferritin Reagent Kit
326ALINITY i Ferritin Calibrators
327ALINITY i Ferritin Controls
328Alinity i Folate Reagent Kit
329Alinity i Folate Calibrators
330Alinity i Folate Controls
331ALINITY i Free PSA Reagent Kit
332ALINITY i Free PSA Calibrators
333ALINITY i Free PSA Controls
334Alinity i Free T3 Reagent Kit
335Alinity i Free T3 Calibrators
336Alinity i Free T3 Controls
337Alinity i Free T4 Reagent Kit
338Alinity i Free T4 Calibrators
339Alinity i Free T4 Controls
340Alinity i FSH Reagent Kit
341Alinity i FSH Calibrators
342Alinity i FSH Controls
343ALINITY i HE4 Reagent Kit (2 x 100 Tests)
344ALINITY i HE4 Calibrators
345ALINITY i HE4 Controls
346Alinity i STAT High Sensitive Troponin-I Reagent Kit
347Alinity i STAT High Sensitive Troponin-I Calibrators
348Alinity i STAT High Sensitive Troponin-I Controls
349ALINITY i Intact PTH Reagent Kit (2x100 tests)
350ALINITY i Intact PTH Calibrators
351ALINITY i Intact PTH Controls
352Alinity i LH Reagent Kit
353Alinity i LH Calibrators
354Alinity i Progesterone Reagent Kit
355Alinity i Progesterone Manual Diluent
356Alinity i Progesterone Calibrators
357Alinity i Progesterone Controls
358ALINITY i PROLACTIN Reagent Kit
359ALINITY i PROLACTIN Calibrators
360ALINITY i PROLACTIN Controls
361ALINITY i 2nd Generation Testosterone Reagent Kit (2x100 Tests)
362ALINITY i 2nd Generation Testosterone Calibrators
363ALINITY i 2nd Generation Testosterone Controls
364ALINITY i Total PSA Reagent Kit
365ALINITY i Total PSA Calibrators
366ALINITY i Total PSA Controls
367ALINITY i TSH Reagent Kit
368ALINITY i TSH Calibrators
369ALINITY i TSH Controls
370ALINITY i 25-OH Vitamin D Reagent Kit
371ALINITY i 25-OH Vitamin D Calibrators
372ALINITY i 25-OH Vitamin D Controls
373Alinity i Folate Manual Diluent
374Alinity i Folate RBC Lysis Diluent
375Alinity i Folate Lysis Reagent
376Alinity i Total T3 Reagent Kit
377Alinity i Total T3 Calibrators
378Alinity i Total T3 Manual Diluent
379Alinity i Total T4 reagent Kit
380Alinity i Total T4 Calibrators
381Alinity i Total T4 Controls
382Alinity i Anti-TPO Calibrators
383Alinity i Anti-TPO Controls
384Alinity i Anti-TPO Reagent Kit
385Alinity i Anti-CCP Calibrators
386Alinity i Anti-CCP Controls
387Alinity i Anti-CCP Reagent Kit
388Alinity i Homocysteine Calibrators
389Alinity i Homocysteine Controls
390Alinity i Homocysteine Reagent Kit
391Alinity i Insulin Calibrators
392Alinity i Insulin Controls
393Alinity i Insulin Reagent Kit
394Alinity i ProGRP Calibrators
395Alinity i ProGRP Controls
396Alinity i ProGRP Reagent Kit
397Alinity i SCC Calibrators
398Alinity i SCC Reagent Kit
399Multichem IA Plus
400ALINITY i Anti-HBc II Reagent Kit
401ALINITY i Anti-HBc II Calibrator
402ALINITY i Anti-HBc II Controls
403ALINITY i Anti-HBc IgM Reagent Kit
404ALINITY i Anti-HBc IgM Calibrators
405ALINITY i Anti-HBc IgM Controls
406ALINITY i Anti-HBe Reagent Kit
407ALINITY i Anti-HBe Calibrator
408ALINITY i Anti-HBe Controls
409ALINITY i Anti-HCV Reagent Kit
410ALINITY i Anti-HCV Calibrator
411ALINITY i Anti-HCV Controls
412ALINITY i Anti-HBs Reagent Kit
413ALINITY i Anti-HBs Calibrators
414ALINITY i Anti-HBs Controls
415ALINITY i CMV IgG Reagent Kit
416ALINITY i CMV IgG Calibrators
417ALINITY i CMV IgG Controls
418ALINITY i CMV IgG Avidity Reagent Kit
419ALINITY i CMV IgG Avidity Controls
420ALINITY i CMV IgM Reagent Kit
421ALINITY i CMV IgM Calibrator
422ALINITY i CMV IgM Controls
423Alinity i HAVAb IgG Reagent Kit
424ALINITY i HAVAb IgG Reagent Kit
425ALINITY i HAVAb IgG Calibrator
426ALINITY i HAVAb IgG Controls
427ALINITY i HAVAb IgM Reagent Kit
428ALINITY i HAVAb IgM Calibrator
429ALINITY i HAVAb IgM Controls
430ALINITY i HBeAg Reagent Kit
431ALINITY i HBeAg Calibrators
432ALINITY i HBeAg Controls
433ALINITY i HBsAg Qualitative II Reagent Kit
434ALINITY i HBsAg Qualitative II Calibrators
435ALINITY i HBsAg Qualitative II Controls
436ALINITY i HBsAg Qualitative II Confirmatory Reagent Kit
437ALINITY i HBsAg Qualitative II Confirmatory Manual Diluent
438ALINITY i HBsAg Reagent Kit
439ALINITY i HBsAg Calibrators
440ALINITY i HBsAg Manual Diluent
441ALINITY i HIV Ag/Ab Combo Reagent Kit
442ALINITY I HIV Ag/Ab Combo Calibrator
443ALINITY i HIV Ag/Ab Combo Controls
444ALINITY i Rubella IgG Reagent Kit
445ALINITY i Rubella IgG Calibrators
446ALINITY i Rubella IgG Controls
447ALINITY i Rubella IgM Reagent Kit
448ALINITY i Rubella IgM Calibrator
449ALINITY i Rubella IgM Controls
450Alinity i Syphilis TP Reagent Kit (2 x 100 Tests)
451Alinity i Syphilis TP Reagent Kit (2 x 600 Tests)
452Alinity i Syphilis TP Calibrator
453Alinity i Syphilis TP Controls
454ALINITY i Toxo IgG Reagent Kit (2x100 Tests)
455ALINITY i Toxo IgG Reagent Kit (2x500 Tests)
456ALINITY i Toxo IgG Calibrators
457ALINITY i Toxo IgG Controls
458ALINITY i Toxo IgG Avidity Reagent Kit
459ALINITY i Toxo IgG Avidity Controls
460ALINITY i Toxo IgM Reagent Kit (2 x 100 Tests)
461ALINITY i Toxo IgM Reagent Kit (2 x 500 Tests)
462ALINITY i Toxo IgM Calibrator
463ALINITY i Toxo IgM Controls
464ALINITY i Anti-HBs Specimen Diluent
465ALINITY i CMV IgG Reagent Kit
466ALINITY i CMV IgM Reagent Kit
467ALINITY i HBsAg Reagent Kit
468ALINITY i HBsAg Controls
469ALINITY i HBsAg Confirmatory V.1 Reagent Kit
470ALINITY i HBsAg Confirmatory V.1 Calibrators
471ALINITY i HBsAg Confirmatory V.1 Controls
472ALINITY i HBeAg Quantitative Calibrators
473ALINITY i HBeAg Quantitative Controls
474Alinity i EBV VCA IgG Calibrator
475Alinity i EBV VCA IgG Controls
476Alinity i EBV VCA IgG Reagent Kit
477Alinity i EBV VCA IgM Calibrator
478Alinity i EBV VCA IgM Controls
479Alinity i EBV VCA IgM Reagent Kit
480Alinity i EBV ENBA-1 IgG Calibrator
481Alinity i EBV ENBA-1 IgG Controls
482Alinity i EBV ENBA-1 IgG Reagent Kit
483SARS-CoV-2 IgG Calibrator Kit
484SARS-CoV-2 IgG Control Kit
485SARS-CoV-2 IgG Reagent Kit
486SARS-CoV-2 IgM Calibrator Kit
487SARS-CoV-2 IgM Control Kit
488SARS-CoV-2 IgM Reagent Kit
489Alinity i HCV Ag Calibrators
490Alinity i HCV Ag Controls
491Alinity i HCV Ag Reagent Kit (2x100 Tests)

Công bố đủ điều kiện mua bán trang thiết bị y tế

Hồ sơ kèm theo gồm:


Cơ sở công bố đủ điều kiện mua bán trang thiết bị y tế cam kết:

1. Nội dung thông tin công bố là chính xác, hợp pháp và theo đúng quy định. Nếu có sự giả mạo, không đúng sự thật cơ sở xin chịu hoàn toàn trách nhiệm và sẽ bị xử lý theo quy định của pháp luật.

2. Bảo đảm chất lượng và lưu hành trang thiết bị y tế theo đúng quy định của pháp luật.

3. Thông báo cho Sở Y tế Hà Nội nếu có một trong các thay đổi liên quan đến hồ sơ công bố.

Người đại diện hợp pháp của cơ sở

Ký tên (Ghi họ tên đầy đủ, chức danh)