Identity
- Trade Name
- Hemoglobin Variants System FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, reagent FDA UDI
- Device Name
- Hemoglobin Variants System Cation Exchange Mini-Columns FDA UDI
- Model / Reference
- 250-0014 FDA UDI
- Description
- Hemoglobin Variants System Cation Exchange Mini-Columns FDA UDI
Identifiers
- Catalog Number
- 2500014 FDA UDI
- Primary DI / UDI-DI
- 00847817006791 FDA UDI
- 510(k) Number
- K171664 FDA UDI
- FDA Product Code
- LDM FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2260 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, reagent
Hemoglobin Variants System by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Inherited haemoglobinopathy IVD, reagent.
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- SPIFE 4000 Alkaline Hemoglobin Gel Kit — Helena Laboratories, Corp. · Class II
- Beta-Thal HbA2 Quik Column Kit — Helena Laboratories, Corp. · Class II
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- QuickGel Applicator Blade and Shallow Well Cups — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 8d62a8ba-cbb2-4698-ac36-111e7bdc80e2 37 fields · synced Jun 8, 2026