Identity
- Trade Name
- Hemoglobin Variants System FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, control FDA UDI
- Device Name
- Hemoglobin Variants System Calibrator Set FDA UDI
- Model / Reference
- 250-0015 FDA UDI
- Description
- Hemoglobin Variants System Calibrator Set FDA UDI
Identifiers
- Catalog Number
- 2500015 FDA UDI
- Primary DI / UDI-DI
- 00847817007170 FDA UDI
- 510(k) Number
- K171664 FDA UDI
- FDA Product Code
- GKA FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, control 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, control
Hemoglobin Variants System by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inherited haemoglobinopathy IVD, control.
- Hemoglobin A2 Elevated Control — Analytical Control Systems · Class II
- Hemoglobin AFSC Control — Analytical Control Systems · Class II
- Hemoglobin Variant Control Kit — Analytical Control Systems
- ASA2 Hemo Control — Helena Laboratories, Corp. · Class II
- HemoglobinAG Philadelphia Control — Analytical Control Systems · Class II
- Hemoglobin FAS Control — Analytical Control Systems · Class II
- AA2 Hemo Control — Helena Laboratories, Corp. · Class II
- AFSC Hemo Control — Helena Laboratories, Corp. · Class II
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 17f8ef5a-047a-41a4-ad48-648168122750 37 fields · synced May 30, 2026