SPECTROLYSE PAI-1 101201

GUDID 00850201006109

Biomedica ADI Inc.

Plasminogen activator inhibitor IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850201006109
NIH Device Record Keyf730b420-1620-433e-94c5-5619e991496b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPECTROLYSE PAI-1
Version Model Number101201
Catalog Number101201
Company DUNS080600606
Company NameBiomedica ADI 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850201006109 [Primary]

FDA Product Code

GGPTEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

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 Date2016-09-20

Devices Manufactured by Biomedica ADI Inc.

00850201006017 - DVVtest 102018-03-29
00850201006024 - DVVconfirm 52018-03-29
00850201006031 - ACTICHROME Heparin (Anti-FIIa)2018-03-29
00850201006048 - IMUBIND PLASMA PAI-1 ELISA2018-03-29
00850201006055 - ACTICLOT dPT2018-03-29
00850201006062 - DVVtest 252018-03-29
00850201006079 - ACTICHROME HEPARIN (ANTI-FXA)2018-03-29
00850201006086 - ACTICHROME ATIII KIT2018-03-29

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