Identity
- Trade Name
- D-10 FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Device Name
- D-10 Hemoglobin A1c Program Calibrator/Diluent Set FDA UDI
- Model / Reference
- 220-0118 FDA UDI
- Description
- D-10 Hemoglobin A1c Program Calibrator/Diluent Set FDA UDI
Identifiers
- Catalog Number
- 2200118 FDA UDI
- Primary DI / UDI-DI
- 00847817003356 FDA UDI
- FDA Product Code
- JIT FDA UDILCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI864.7470 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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, calibrator
D-10 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, calibrator.
- Diazyme — Diazyme Laboratories, Inc.
- Alfa Wassermann — Alfa Wassermann, Inc. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- HbA1C CAL — Randox Laboratories, Ltd. · Class II
- Chemistry HbA1c Calibrator Kit — Medica Corp. · Class II
- Trinity Biotech — Primus Corp. · Class II
- HbA1c II CALIBRATOR SET (HbA1c II CAL) — Randox Laboratories, Ltd. · Class II
- Direct Glycohemoglobin (HbA1c) Calibrator Set — STANBIO LABORATORY, L.P. · Class II
Cleared under the same submission
K031043 also covers:
K041444 also covers:
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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI c952de7b-cbb8-4533-bd7a-5b469191be4b 37 fields · synced May 30, 2026