CLIAWAIVED INC CLIA-INGM-MC42

GUDID 00183278000436

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

Primary Device ID	00183278000436
NIH Device Record Key	782d4203-6c9e-4f04-968a-b71742011631
Commercial Distribution Status	In Commercial Distribution
Brand Name	CLIAWAIVED INC
Version Model Number	CLIA-INGM-MC42
Catalog Number	CLIA-INGM-MC42
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	00183278000436 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

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