Identity
- Trade Name
- D-10 Dual FDA UDI
- Generic Name
- Haemoglobin A2 (HbA2) IVD, calibrator FDA UDI
- Device Name
- D-10 Dual Program HbA2/F/A1c Calibrator/Diluent Set FDA UDI
- Model / Reference
- 220-0218 FDA UDI
- Description
- D-10 Dual Program HbA2/F/A1c Calibrator/Diluent Set FDA UDI
Identifiers
- Catalog Number
- 2200218 FDA UDI
- Primary DI / UDI-DI
- 00847817003509 FDA UDI
- 510(k) Number
- K041444 FDA UDI
- FDA Product Code
- LCP FDA UDIJPD FDA UDIJIT FDA UDI
- GMDN Term
- Haemoglobin A2 (HbA2) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI864.7400 FDA UDI862.1150 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, calibratorHaemoglobin A2 (HbA2) IVD, calibratorHaemoglobin F (HbF) IVD, calibrator
D-10 Dual by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemoglobin A2 (HbA2) IVD, calibrator.
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Cleared under the same submission
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 4da5d8d5-a3d2-4864-b7d2-963d5609c656 37 fields · synced May 30, 2026