Identity
- Trade Name
- Secondary reagents immunoblot (IgM) FDA UDI
- Generic Name
- Enzyme immunoassay (EIA) generic reagent kit IVD FDA UDI
- Model / Reference
- ZD 1129-0101-1 M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016151692 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Enzyme immunoassay (EIA) generic reagent kit IVD
Secondary reagents immunoblot (IgM) by EUROIMMUN Medizinische Labordiagnostika AG — 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
- Serum Diluent IgM — SAVYON DIAGNOSTICS LTD · Class I
- Conjugate IgA — SAVYON DIAGNOSTICS LTD · Class I
- Conjugate IgM — SAVYON DIAGNOSTICS LTD · Class I
- Secondary reagents immunoblot (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · 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
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 7ad412be-6f02-4858-a1d3-09ca8f246ac2 33 fields · synced May 30, 2026