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Panels › Microbiology › Product code JSS · Class 1

Kit, Identification, Enterobacteriaceae

Regulation 866.2660

0510(k)s in 12 months (49 all time)
0recalls in 12 months (9 all time)
5recalls that name a 510(k)
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Top companies in JSS

Company510(k)sRecalls
Advandx, Inc.75
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Vitek Systems, Inc.30
Abbott Laboratories20
Austin Biological Laboratories20
Becton Dickinson & Co.02
Becton Dickinson Microbiology Systems20
Biomerieux Inc02
Cnr Labs20
Dms Products, Inc.20
DateFirm and productCodeLinked 510(k)
Jan 4, 2023Biomerieux Inc
API 20 E 25 STRIPS, CATALOG 20100
Open, Classified		 JSSNone listed
Nov 9, 2021Biomerieux Inc
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Terminated		 JSSNone listed
Jul 11, 2014Becton Dickinson & Co.
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family E
Terminated		 JSSK926018
Jan 2, 2014AdvanDx, Inc.
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichi
Terminated		 JSSK123418
Jan 20, 2013Becton Dickinson & Co.
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermen
Terminated		 JSSK926018
Oct 22, 2012Advandx Inc
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traf
Terminated		 JSSNone listed
Oct 22, 2012Advandx Inc
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH i
Terminated		 JSSNone listed
Dec 1, 2010AdvanDx, Inc.
AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aerugin
Terminated		 JSSK092393
Nov 29, 2010AdvanDx, Inc.
AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007
Terminated		 JSSK092236

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