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Helicobacter pylori Rabbit Polyclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Helicobacter pylori Rabbit Polyclonal Antibody FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Model / Reference
- 215A-75-ASR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683143796 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD 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: Assay development analyte-specific reagent IVD
Helicobacter pylori Rabbit Polyclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI cdbce490-9934-4c76-8e44-63bbaa59830b 33 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 2, 2026