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Panels › Microbiology › Product code JTY · Class 2

Culture Media, For Isolation Of Pathogenic Neisseria

Regulation 866.2410

0510(k)s in 12 months (83 all time)
1recalls in 12 months (9 all time)
5recalls that name a 510(k)
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Top companies in JTY

Company510(k)sRecalls
Becton Dickinson & Co07
Granite Diagnostics, Inc.60
Gibco Laboratories Life Technologies, Inc.50
Isle Media and Sterile Products, Inc.50
Otisville Biotech, Inc.50
Flow Laboratories, Inc.40
Acumedia Manufacturers, Inc.30
American Laboratory Supply, Inc.30
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Bioclinical Systems, Inc.30
DateFirm and productCodeLinked 510(k)
Jun 30, 2026Remel, Inc
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Open, Classified		 JTYK954986
Dec 9, 2022Becton Dickinson & Co.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Open, Classified		 JTYNone listed
Mar 17, 2021Becton Dickinson & Co.
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
Terminated		 JTYK770287
Mar 17, 2021Becton Dickinson & Co.
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
Terminated		 JTYK770287
Jun 21, 2018Becton Dickinson & Co.
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.
Terminated		 JTYK864803
May 3, 2013Becton Dickinson & Co.
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Rea
Terminated		 JTYK081825
K090827 +2
Nov 27, 2003Becton Dickinson & Co
Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton.
Terminated		 JTYNone listed
Oct 24, 2003Remel, Inc
Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
Terminated		 JTYNone listed
Dec 18, 2002Becton Dickinson & Co.
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267
Terminated		 JTYNone listed

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