UDI device identifier
CLIAWAIVED INC CLIA-INGM-MC42S
UDI device identifier 00183278000443 · Cliawaived, Inc.
Key facts
| Primary DI | 00183278000443 |
|---|---|
| Brand name | CLIAWAIVED INC |
| Version or model | CLIA-INGM-MC42S |
| Catalog number | CLIA-INGM-MC42S |
| Company | Cliawaived, Inc. |
| DUNS number | 969635304 |
| GMDN term | SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Mar 27, 2020 |
| Version date | Jun 10, 2022 |
| 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) |
At a glance
- None MAUDE reports citing this UDI
- No Linked premarket submission
- No EUDAMED counterpart found
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: