Identity
- Trade Name
- VARIANT II B-thalassemia FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
- Device Name
- VARIANT II B-thalassemia Short Program Reorder Pack FDA UDI
- Model / Reference
- 270-2154 FDA UDI
- Description
- VARIANT II B-thalassemia Short Program Reorder Pack FDA UDI
Identifiers
- Catalog Number
- 2702154 FDA UDI
- Primary DI / UDI-DI
- 00847817000447 FDA UDI
- 510(k) Number
- K991127 FDA UDI
- FDA Product Code
- JPD FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7400 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
VARIANT II B-thalassemia 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
K991127 also covers:
- VARIANT II B-thalassemia — Bio-Rad Laboratories
- VARIANT II B-thalassemia — Bio-Rad Laboratories
- VARIANT II B-thalassemia — Bio-Rad Laboratories
- VARIANT II B-thalassemia — Bio-Rad Laboratories
- VARIANT II B-thalassemia — Bio-Rad Laboratories
- VARIANT II B-thalassemia — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 63ea6b83-d8eb-4b03-a569-4547cd87504f 37 fields · synced May 31, 2026