ClearanceBrief
Panels › Microbiology › Product code GTZ · Class 1

Antisera, All Groups, Streptococcus Spp.

Regulation 866.3740

0510(k)s in 12 months (105 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in GTZ

Company510(k)sRecalls
Abbott Laboratories90
Quidel Corp.80
Bd Becton Dickinson Vacutainer Systems Preanalytic70
Binax, Inc.60
Diagnostic Products Corp.40
Pharmacia, Inc.40
Armkel, LLC30
Difco Laboratories, Inc.30
Leeco Diagnostics, Inc.30
Medix Biotech, Inc.30
DateFirm and productCodeLinked 510(k)
Sep 19, 2024Cypress Medical Products LLC
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Open, Classified		 GTZK012521
Jun 24, 2009Binax, Inc. dba IMPD
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
Terminated		 GTZK962060
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
Terminated		 GTZK971522

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