CLIAWAIVED INC CLIA-INGM-MC42S

GUDID 00183278000443

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00183278000443
NIH Device Record Key	6dffd826-0ab6-46d9-923a-8079a26508a4
Commercial Distribution Status	In Commercial Distribution
Brand Name	CLIAWAIVED INC
Version Model Number	CLIA-INGM-MC42S
Catalog Number	CLIA-INGM-MC42S
Company DUNS	969635304
Company Name	Cliawaived, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00183278000443 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

00816610020440	CLIAWaived Inc. Thyroid Test Rapid TSH cassette (whole blood)
00816610020402	Thyrochek One-Step Whole Blood Rapid TSH Assay
00183278000436	CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 in
00183278000443	CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Onl