Identity
- Trade Name
- Anti-panHb APC FDA UDI
- Generic Name
- Haemoglobin detection IVD, antibody FDA UDI
- Device Name
- The APC conjugated monoclonal antibody anti-pan Hemoglobin (panHb) antibody recognizes the α-chain of human hemoglobin. FDA UDI
- Model / Reference
- IQP-575A FDA UDI
- Description
- The APC conjugated monoclonal antibody anti-pan Hemoglobin (panHb) antibody recognizes the α-chain of human hemoglobin. FDA UDI
Identifiers
- Catalog Number
- IQP-575A FDA UDI
- Primary DI / UDI-DI
- 08719327451007 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Haemoglobin detection IVD, antibody 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 detection IVD, antibody
Anti-panHb APC by IQ Products B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemoglobin detection IVD, antibody.
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- Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Hemoglobin alpha Antibody, EP124 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Hemoglobin alpha Antibody, EP124 — EPITOMICS, INC. · Class I
- Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Hemoglobin A (EPR3608) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Hemoglobin alpha Antibody, EP124 — EPITOMICS, INC. · Class I
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 73811c10-f421-4518-a8d5-1e1aff99aefe 35 fields · synced May 31, 2026