EL-ANCA: anti-PR3 104-115

GUDID 00854473003231

ANTI-PROTEINASE-3 (PR3) ANTIBODIES (C-ANCA) ELISA TEST KIT, 96 TESTS

THERA-TEST LABORATORIES, INC

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00854473003231
NIH Device Record Keyb0394eb2-0e58-4202-8288-e0414598699f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEL-ANCA: anti-PR3
Version Model Number104-115
Catalog Number104-115
Company DUNS194336954
Company NameTHERA-TEST LABORATORIES, 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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854473003231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-15

Devices Manufactured by THERA-TEST LABORATORIES, INC

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