Identity
- Trade Name
- CLIAWAIVED INC FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Only" (Single kit includes 1 device, 1 lancets, 1 dropper, 1 single use buffer, 1 alcohol wipe, 1 procedure card and insert) FDA UDI
- Model / Reference
- CLIA-INGM-MC42S FDA UDI
- Description
- CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Only" (Single kit includes 1 device, 1 lancets, 1 dropper, 1 single use buffer, 1 alcohol wipe, 1 procedure card and insert) FDA UDI
Identifiers
- Catalog Number
- CLIA-INGM-MC42S FDA UDI
- Primary DI / UDI-DI
- 00183278000443 FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinicalSARS-CoV-1 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
Cliawaived Inc by Cliawaived, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-1 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical.
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
- Cliawaived, Inc.
Sources (1)
- FDA UDI 6dffd826-0ab6-46d9-923a-8079a26508a4 35 fields · synced Jun 6, 2026