CLIAWAIVED INC CLIA-INGM-MC42

GUDID 00183278000436

CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)

Cliawaived, Inc.

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Primary Device ID00183278000436
NIH Device Record Key782d4203-6c9e-4f04-968a-b71742011631
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLIAWAIVED INC
Version Model NumberCLIA-INGM-MC42
Catalog NumberCLIA-INGM-MC42
Company DUNS969635304
Company NameCliawaived, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com
Phone1-888-882-7739
Emailinfo@cliawaived.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100183278000436 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2020-03-26

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00183278000436CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 in
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