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Panels › Microbiology › Product code JTR · Class 1

Kit, Quality Control For Culture Media

Regulation 866.2480

0510(k)s in 12 months (12 all time)
4recalls in 12 months (46 all time)
40recalls that name a 510(k)
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Top companies in JTR

Company510(k)sRecalls
Microbiologics Inc042
Micro-Bio-Logics30
PML, Inc. dba Pml Microbiologicals Inc.03
American Scientific Products10
American Type Culture Collection10
Austin Biological Laboratories10
Biological and Environmental Control Laboratories Inc01
Biological & Environmental Control Laboratories10
Lab Ability, Inc.10
Pro-Lab, Inc.10
DateFirm and productCodeLinked 510(k)
Dec 22, 2025Microbiologics Inc
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Open, Classified
JTRK861022
Dec 22, 2025Microbiologics Inc
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Open, Classified
JTRK861022
Dec 22, 2025Microbiologics Inc
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Open, Classified
JTRK861022
Dec 2, 2025Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Open, Classified
JTRNone listed
Jul 29, 2025Microbiologics Inc
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Open, Classified
JTRNone listed
Jul 29, 2025Microbiologics Inc
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Open, Classified
JTRK861022
Jul 17, 2025Microbiologics Inc
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Open, Classified
JTRK861022
Jun 11, 2025Microbiologics Inc
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Open, Classified
JTRK861022
Apr 5, 2024Microbiologics Inc
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Open, Classified
JTRK861022
Nov 15, 2023Microbiologics Inc
LYFO-DISK, P. venetum, Catalog number 0794L
Open, Classified
JTRK861022
Nov 15, 2023Microbiologics Inc
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Open, Classified
JTRK861022
Sep 11, 2023Microbiologics Inc
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Open, Classified
JTRK861022
May 6, 2022Microbiologics Inc
KWIK-STIK" plus: Clostridium perfringens
Terminated
JTRK861022
Feb 8, 2022Microbiologics Inc
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Terminated
JTRK861022
Feb 8, 2022Microbiologics Inc
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Terminated
JTRK861022
Feb 8, 2022Microbiologics Inc
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Terminated
JTRK861022
Feb 8, 2022Microbiologics Inc
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Terminated
JTRK861022
Feb 8, 2022Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Terminated
JTRK861022
Jan 31, 2022Microbiologics Inc
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Terminated
JTRK861022
Jan 28, 2022Microbiologics Inc
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Terminated
JTRK861022
Dec 16, 2020Microbiologics Inc
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Terminated
JTRK861022
Dec 16, 2020Microbiologics Inc
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Terminated
JTRK861022
Oct 8, 2020Microbiologics Inc
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Terminated
JTRK861022
Oct 8, 2020Microbiologics Inc
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to pre
Terminated
JTRK861022
Oct 8, 2020Microbiologics Inc
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to pre
Terminated
JTRK861022
Oct 8, 2020Microbiologics Inc
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to pre
Terminated
JTRK861022
Oct 8, 2020Microbiologics Inc
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in mi
Terminated
JTRK861022
Oct 1, 2020Microbiologics Inc
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and
Terminated
JTRK861022
Oct 1, 2020Microbiologics Inc
LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets an
Terminated
JTRK861022
Oct 1, 2020Microbiologics Inc
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized micro
Terminated
JTRK861022
Feb 12, 2020Microbiologics Inc
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
Terminated
JTRK861022
Feb 12, 2020Microbiologics Inc
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Terminated
JTRK861022
Mar 2, 2017Microbiologics Inc
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and conta
Terminated
JTRK861022
Mar 2, 2017Microbiologics Inc
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating
Terminated
JTRK861022
Dec 1, 2015Microbiologics Inc
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Gr
Terminated
JTRK861022
Dec 1, 2015Microbiologics Inc
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (G
Terminated
JTRK861022
Jul 17, 2015Microbiologics Inc
LYFO Disk
Completed
JTRK861022
Oct 6, 2014Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Terminated
JTRK861022
Oct 6, 2014Microbiologics Inc
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Terminated
JTRK861022
Oct 6, 2014Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Terminated
JTRK861022
Mar 25, 2013Microbiologics Inc
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Terminated
JTRK861022
Feb 15, 2008PML, Inc. dba Pml Microbiologicals Inc.
PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070
Terminated
JTRNone listed
Feb 15, 2008PML, Inc. dba Pml Microbiologicals Inc.
PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 271
Terminated
JTRNone listed
Feb 15, 2008PML, Inc. dba Pml Microbiologicals Inc.
PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95t
Terminated
JTRNone listed
Dec 29, 2007Microbiologics Inc
MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)
Terminated
JTRK861022
Apr 20, 2006Biological and Environmental Control Laboratories Inc
Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek Microbial Suspensions/Aspergillus ni
Terminated
JTRNone listed

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