BioHermes A1cChek Pro Glycohemoglobin Test Kit
FDA UDIEUDAMEDIdentity
- Trade Name
- BioHermes A1cChek Pro Glycohemoglobin Test Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- A1cChek Pro Glycohemoglobin Test Kit EUDAMEDA1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tests/Kit. Intended use: This A1cChek Pro Glycohemoglobin Test Kit is intended to be used with the A1cChek Pro Glycohemoglobin Analyzer to quantitatively measure hemoglobin A1c(HbA1c) level in whole blood (capillary blood or venous blood).This test kit is for professional use. Contents: Code Chip x 1 piece; HbA1c Test Strip x 100 pieces; Sampler x 100 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle; Blood Collector x 100 pieces. FDA UDI
- Model / Reference
- A1C-PRO S01 EUDAMEDFDA UDIA1C-S32 EUDAMED
- Description
- A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tests/Kit. Intended use: This A1cChek Pro Glycohemoglobin Test Kit is intended to be used with the A1cChek Pro Glycohemoglobin Analyzer to quantitatively measure hemoglobin A1c(HbA1c) level in whole blood (capillary blood or venous blood).This test kit is for professional use. Contents: Code Chip x 1 piece; HbA1c Test Strip x 100 pieces; Sampler x 100 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle; Blood Collector x 100 pieces. FDA UDI
Identifiers
- Catalog Number
- A1C-S32 FDA UDI
- Primary DI / UDI-DI
- 16935784400061 EUDAMED06935784400064 FDA UDI
- Basic UDI-DI
- B-16935784400061 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
BioHermes A1cChek Pro Glycohemoglobin Test Kit by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Sources (2)
- FDA UDI 4d3ff21c-13f1-4571-80e5-a4af14598c8d 34 fields · synced Aug 1, 2026
- EUDAMED bdb1943d-d925-4ad7-b4c1-477471893f77 61 fields · synced Aug 1, 2026