12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·September 20, 2023
KWIK-STIK" plus: Clostridium perfringens
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·June 1, 2022
Cepheid Xpert C. difficile/Epi Control Panel
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·June 26, 2019
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 9, 2022
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 9, 2022
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 contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 16, 2022
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 16, 2022
LYFO Disk
FDA Enforcement
Class III
·Completed·Microbiologics Inc·March 23, 2022
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 9, 2022
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 23, 2022
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 swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 16, 2022
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·September 21, 2022