Identity
- Trade Name
- D-100 FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Device Name
- D-100 Cleaning Tube FDA UDI
- Model / Reference
- 290-1008 FDA UDI
- Description
- D-100 Cleaning Tube FDA UDI
Identifiers
- Catalog Number
- 2901008 FDA UDI
- Primary DI / UDI-DI
- 00847817015991 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, reagent
D-100 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, reagent.
- Trinity Biotech — Primus Corp. · Class II
- Trinity Biotech — Primus Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- ACE — Alfa Wassermann, Inc. · Class II
- Trinity Biotech — Primus Corp. · Class II
- Pointe Scientific, Inc. Gyco Lyse — POINTE SCIENTIFIC, INC. · Class II
- HEMOLYSIS WASHING SOLUTION 80H — ARKRAY USA, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI d3578954-ab88-4c2e-a9c1-8dacf1b5129f 36 fields · synced May 30, 2026