Identity
- Trade Name
- Conjugate IgA FDA UDI
- Generic Name
- Enzyme immunoassay (EIA) generic reagent kit IVD FDA UDI
- Device Name
- Conjugate IgA FDA UDI
- Model / Reference
- FA233-12M FDA UDI
- Description
- Conjugate IgA FDA UDI
Identifiers
- Catalog Number
- FA233-12M FDA UDI
- Primary DI / UDI-DI
- 07290013348302 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Enzyme immunoassay (EIA) generic reagent kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
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: Enzyme immunoassay (EIA) generic reagent kit IVD
Conjugate IgA by Savyon Diagnostics Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enzyme immunoassay (EIA) generic reagent kit IVD.
- IgG Component Pack - Bulk — Gold Standard Diagnostics, LLC · Class I
- IgM Component Pack - Bulk — Gold Standard Diagnostics, LLC · Class I
- Secondary reagents immunoblot (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Secondary reagents immunoblot (IgM) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Serum Diluent IgM — SAVYON DIAGNOSTICS LTD · Class I
- Conjugate IgM — SAVYON DIAGNOSTICS LTD · 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
- Savyon Diagnostics Ltd
Sources (1)
- FDA UDI cd808141-9f17-4606-acbd-19b4aa2e2cc8 35 fields · synced Jun 6, 2026