Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Hemoglobin A1c FDA UDI
- Model / Reference
- 2K96-20 FDA UDI
- Description
- Hemoglobin A1c FDA UDI
Identifiers
- Catalog Number
- 02K9620 FDA UDI
- Primary DI / UDI-DI
- 00380740003623 FDA UDI
- FDA Product Code
- GGM FDA UDIKRZ FDA UDILCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI864.8165 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
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry.
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- ARCHITECT — Abbott · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Tina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics Corp. · Class II
- Tinaquant Hemoglobin A1c Gen2 Whole blood and Hemolysate Application — Roche Diagnostics Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, 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 |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI c60a57cf-5b20-454a-b8ac-4dde94fb561b 36 fields · synced May 29, 2026