Identity
- Trade Name
- BioHermes Glycohemoglobin Test Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- A1cChek Express Glycohemoglobin Test Kit EUDAMEDA1cChek Express Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 25 Tests/Kit . Intended use: This A1cChek Express glycohemoglobin test kit is intended to be used with the A1cChek Express glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c)level in whole blood (capillary blood or venous blood). Contents: HbA1c Test Strip x 25; Sampler x 25; Buffer Kit x 1; Rinse Card x 1; Code Chip x 1; lnsert x 1. FDA UDI
- Model / Reference
- A1C-EXP S01 EUDAMEDFDA UDIA1C-S42 EUDAMED
- Description
- A1cChek Express Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 25 Tests/Kit . Intended use: This A1cChek Express glycohemoglobin test kit is intended to be used with the A1cChek Express glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c)level in whole blood (capillary blood or venous blood). Contents: HbA1c Test Strip x 25; Sampler x 25; Buffer Kit x 1; Rinse Card x 1; Code Chip x 1; lnsert x 1. FDA UDI
Identifiers
- Catalog Number
- A1C-S42 FDA UDI
- Primary DI / UDI-DI
- 06935784411176 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784411176 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 Glycohemoglobin Test Kit by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography.
- Trinity Biotech — Primus Corp. · Class II
- Trinity Biotech — Primus Corp. · Class II
- D-10 Dual — Bio-Rad Laboratories · Class II
- VARIANT II TURBO — Bio-Rad Laboratories · Class II
- D-10 — Bio-Rad Laboratories · Class II
- VARIANT II Hemoglobin A1c — Bio-Rad Laboratories · Class II
- TSKgel G8 Variant HSi — Tosoh Corp. · Class II
- Hemoglobin Capillary Collection System (HCCS) — Bio-Rad Laboratories · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Sources (2)
- FDA UDI f090a335-aa82-4a6d-9522-a52d551026d5 34 fields · synced Jul 16, 2026
- EUDAMED 6607d76c-31a7-41fd-91ee-84fc84675182 61 fields · synced Jul 16, 2026