UDI device identifier

CLIAWAIVED INC CLIA-INGM-MC42

UDI device identifier 00183278000436 · Cliawaived, Inc.

Key facts

Primary DI 00183278000436
Brand name CLIAWAIVED INC
Version or model CLIA-INGM-MC42
Catalog number CLIA-INGM-MC42
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 26, 2020
Version date Jun 10, 2022
Description CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)

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:

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