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Panels › Microbiology › Product code JTZ · Class 2

Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Regulation 866.1700

1510(k)s in 12 months (75 all time)
1recalls in 12 months (8 all time)
6recalls that name a 510(k)
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Top companies in JTZ

Company510(k)sRecalls
Biomedia, Inc.50
Hardy Media50
Remel Co.23
Mds Laboratories, Inc.40
Biomedica, Inc.30
Gibco Laboratories Life Technologies, Inc.30
Interstate Media30
Isle Media and Sterile Products, Inc.30
Acumedia Manufacturers, Inc.20
Anaerobe Systems20
DateFirm and productCodeLinked 510(k)
Nov 21, 2025Remel, Inc
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Open, Classified		 JTZK790687
K802957
May 4, 2018Thermo Fisher
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistanc
Terminated		 JTZK850291
Nov 2, 2017Remel Inc
CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Terminated		 JTZK802498
Jun 21, 2011Becton Dickinson & Co.
BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus
Terminated		 JTZK863821
Jan 15, 2010Remel, Inc
remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative proced
Terminated		 JTZK850291
Sep 30, 2009Trek Diagnostic Systems
Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Str
Terminated		 JTZK860753
Jan 28, 2009Trek Diagnostic Systems
HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
Terminated		 JTZNone listed
Aug 31, 2005Becton Dickinson & Co.
Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
Terminated		 JTZNone listed

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