CLIAWAIVED INC CLIA-TSH-120-A-KIT

GUDID 00816610020440

CLIAWaived Inc. Thyroid Test Rapid TSH cassette (whole blood)

Cliawaived, Inc.

Thyroid stimulating hormone (TSH) IVD, kit, immunochromatographic test (ICT), self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing
Primary Device ID00816610020440
NIH Device Record Key34bd57f0-fe3b-417b-83d7-8a6aa581583c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLIAWAIVED INC
Version Model NumberCLIA-TSH-120-A-KIT
Catalog NumberCLIA-TSH-120-A-KIT
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
GS100816610020440 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-08
Device Publish Date2019-03-29

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