Identity
- Trade Name
- anti-HbS FITC FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, reagent FDA UDI
- Device Name
- The FITC conjugated monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin. FDA UDI
- Model / Reference
- IQP-574F FDA UDI
- Description
- The FITC conjugated monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin. FDA UDI
Identifiers
- Catalog Number
- IQP-574F FDA UDI
- Primary DI / UDI-DI
- 08719327450994 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Haemoglobin S (HbS) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemoglobin S (HbS) IVD, reagent
anti-HbS FITC by IQ Products B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- IQ Products B.V.
Sources (1)
- FDA UDI fd7af10f-f857-4fc7-b4e0-bb4533b2b56f 36 fields · synced May 30, 2026