Identity
- Trade Name
- VARIANT II TURBO Link FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Device Name
- VARIANT II TURBO Link Hemoglobin A1c Program Analytical Cartridge FDA UDI
- Model / Reference
- 270-2725 FDA UDI
- Description
- VARIANT II TURBO Link Hemoglobin A1c Program Analytical Cartridge FDA UDI
Identifiers
- Catalog Number
- 2702725 FDA UDI
- Primary DI / UDI-DI
- 00847817014895 FDA UDI
- 510(k) Number
- K070819 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
VARIANT II TURBO Link by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070819 also covers:
- VARIANT II TURBO Link — Bio-Rad Laboratories
- VARIANT II TURBO Link — Bio-Rad Laboratories
- VARIANT II TURBO Link — Bio-Rad Laboratories
- VARIANT II TURBO Link — Bio-Rad Laboratories
- VARIANT II TURBO Link — Bio-Rad Laboratories
- VARIANT II TURBO Link — Bio-Rad Laboratories
- VARIANT II TURBO Link — Bio-Rad Laboratories
- Wash/Diluent Solution Set — Bio-Rad Laboratories
- Whole Blood Primer — Bio-Rad Laboratories
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 339d0c17-93c5-481d-86a0-e28adde7a792 37 fields · synced May 30, 2026