Identity
- Trade Name
- Hemoglobin Variants System FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
- Device Name
- Hemoglobin Variants System Reorder Pack FDA UDI
- Model / Reference
- 250-0013 FDA UDI
- Description
- Hemoglobin Variants System Reorder Pack FDA UDI
Identifiers
- Catalog Number
- 2500013 FDA UDI
- Primary DI / UDI-DI
- 00847817007156 FDA UDI
- 510(k) Number
- K171664 FDA UDI
- FDA Product Code
- GKA FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7415 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: Inherited haemoglobinopathy IVD, kit, liquid chromatography
Hemoglobin Variants System 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
K171664 also covers:
- Hemoglobin Variants System — Bio-Rad Laboratories
- Hemoglobin Variants System — Bio-Rad Laboratories
- Hemoglobin Variants System — Bio-Rad Laboratories
- Hemoglobin Variants System — Bio-Rad Laboratories
- Hemoglobin Variants System — Bio-Rad Laboratories
- Hemoglobin Variants System — Bio-Rad Laboratories
- Hemoglobin Variants System — 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 8e61c3c0-8042-421d-a9bb-be5810ab43e4 38 fields · synced May 31, 2026