Anti TPO Ab ELISA EIA-3561

GUDID 00404847435610

Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies against thyroid peroxidase (TPO) in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00404847435610
NIH Device Record Keyab68a351-e928-4f5c-9bcc-9466d9606d60
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti TPO Ab ELISA
Version Model NumberN/A
Catalog NumberEIA-3561
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(973)564-7555
Emailcorp@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100404847435610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JZOSYSTEM, TEST, THYROID AUTOANTIBODY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-18
Device Publish Date2019-06-10

On-Brand Devices [Anti TPO Ab ELISA]

00404847435610Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies
04048474035612Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies

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