Identity
- Trade Name
- EL-Anti-SARS-CoV-2 IgM FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-SARS-CoV-2 IgM ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
- Model / Reference
- 104-129 FDA UDI
- Description
- ANTI-SARS-CoV-2 IgM ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
Identifiers
- Catalog Number
- 104-129 FDA UDI
- Primary DI / UDI-DI
- 00854473003323 FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EL-Anti-SARS-CoV-2 IgM by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI e379e616-c27e-4167-828e-7aca6cce4f9b 36 fields · synced May 30, 2026