← Back to catalogue
Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 04528123160 FDA UDI
Identifiers
- Catalog Number
- 04528123160 FDA UDI
- Primary DI / UDI-DI
- 04015630934560 FDA UDI
- 510(k) Number
- DEN130002 FDA UDI
- FDA Product Code
- PDJ FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1373 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry.
- Dimension Clinical Chemistry System A1C Kit — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Direct Glycohemoglobin (HbA1c) — STANBIO LABORATORY, L.P. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Dimension Vista System Flex reagent cartridge A1C KIT — Siemens Healthcare Diagnostics · 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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI b79d7a18-9465-4d52-99fe-cdf852aea562 35 fields · synced Jun 8, 2026