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)
Top companies in JTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Microbiologics Inc | 0 | 42 |
| Micro-Bio-Logics | 3 | 0 |
| PML, Inc. dba Pml Microbiologicals Inc. | 0 | 3 |
| American Scientific Products | 1 | 0 |
| American Type Culture Collection | 1 | 0 |
| Austin Biological Laboratories | 1 | 0 |
| Biological and Environmental Control Laboratories Inc | 0 | 1 |
| Biological & Environmental Control Laboratories | 1 | 0 |
| Lab Ability, Inc. | 1 | 0 |
| Pro-Lab, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2025 | Microbiologics Inc LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L Open, Classified |
JTR | K861022 |
| Dec 22, 2025 | Microbiologics Inc KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K Open, Classified |
JTR | K861022 |
| Dec 22, 2025 | Microbiologics Inc KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P Open, Classified |
JTR | K861022 |
| Dec 2, 2025 | Microbiologics Inc KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K Open, Classified |
JTR | None listed |
| Jul 29, 2025 | Microbiologics Inc LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L Open, Classified |
JTR | None listed |
| Jul 29, 2025 | Microbiologics Inc LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack) Open, Classified |
JTR | K861022 |
| Jul 17, 2025 | Microbiologics Inc KWIK-STIK and LYFO DISK, quality control kit for culture media
Catalog # 0805K and 0805L Open, Classified |
JTR | K861022 |
| Jun 11, 2025 | Microbiologics 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 |
JTR | K861022 |
| Apr 5, 2024 | Microbiologics Inc KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media Open, Classified |
JTR | K861022 |
| Nov 15, 2023 | Microbiologics Inc LYFO-DISK, P. venetum, Catalog number 0794L Open, Classified |
JTR | K861022 |
| Nov 15, 2023 | Microbiologics Inc KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) Open, Classified |
JTR | K861022 |
| Sep 11, 2023 | Microbiologics Inc KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing Open, Classified |
JTR | K861022 |
| May 6, 2022 | Microbiologics Inc KWIK-STIK" plus: Clostridium perfringens Terminated |
JTR | K861022 |
| Feb 8, 2022 | Microbiologics 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 |
JTR | K861022 |
| Feb 8, 2022 | Microbiologics 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 |
JTR | K861022 |
| Feb 8, 2022 | Microbiologics 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 |
JTR | K861022 |
| Feb 8, 2022 | Microbiologics Inc LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms Terminated |
JTR | K861022 |
| Feb 8, 2022 | Microbiologics 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 |
JTR | K861022 |
| Jan 31, 2022 | Microbiologics Inc KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls. Terminated |
JTR | K861022 |
| Jan 28, 2022 | Microbiologics Inc KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls. Terminated |
JTR | K861022 |
| Dec 16, 2020 | Microbiologics 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 |
JTR | K861022 |
| Dec 16, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 8, 2020 | Microbiologics Inc KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) Terminated |
JTR | K861022 |
| Oct 8, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 8, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 8, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 8, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 1, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 1, 2020 | Microbiologics 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 |
JTR | K861022 |
| Oct 1, 2020 | Microbiologics 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 |
JTR | K861022 |
| Feb 12, 2020 | Microbiologics 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 |
JTR | K861022 |
| Feb 12, 2020 | Microbiologics Inc KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3) Terminated |
JTR | K861022 |
| Mar 2, 2017 | Microbiologics 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 |
JTR | K861022 |
| Mar 2, 2017 | Microbiologics 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 |
JTR | K861022 |
| Dec 1, 2015 | Microbiologics 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 |
JTR | K861022 |
| Dec 1, 2015 | Microbiologics 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 |
JTR | K861022 |
| Jul 17, 2015 | Microbiologics Inc LYFO Disk Completed |
JTR | K861022 |
| Oct 6, 2014 | Microbiologics Inc KWIK-STIK, Quality control kit for culture media, sold as:
KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299 Terminated |
JTR | K861022 |
| Oct 6, 2014 | Microbiologics Inc LYFO-DISK, Quality control kit for culture media, sold as:
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 Terminated |
JTR | K861022 |
| Oct 6, 2014 | Microbiologics 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 |
JTR | K861022 |
| Mar 25, 2013 | Microbiologics 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 |
JTR | K861022 |
| Feb 15, 2008 | PML, 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 |
JTR | None listed |
| Feb 15, 2008 | PML, 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 |
JTR | None listed |
| Feb 15, 2008 | PML, 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 |
JTR | None listed |
| Dec 29, 2007 | Microbiologics 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 |
JTR | K861022 |
| Apr 20, 2006 | Biological 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 |
JTR | None listed |
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