Company ยท US
Microbiologics Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2019. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
67recalls (4 in 12 months)
41recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTR | Kit, Quality Control For Culture Media | 42 |
| OHQ | Multi-Analyte Controls Unassayed | 19 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 12 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 7 |
| JSP | Kit, Anaerobic Identification | 3 |
| LJG | Quality Control Slides | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2019 | K190086 | Cepheid Xpert Respiratory Control Panel Microbiologics, Inc. | PMN |
| Jun 25, 2019 | K191168 | Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc. | PMN |
| Jun 20, 2019 | K191172 | Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc. | PMN |
| May 8, 2019 | K190223 | Cepheid Xpert CT/NG Control Panel Microbiologics, Inc. | PMN |
| Apr 19, 2019 | K190463 | Cepheid Xpert C. difficile/Epi Control Panel Microbiologics, Inc. | PMN |
| Nov 8, 2018 | K182472 | Cepheid Xpert GBS LB Control Panel Microbiologics, Inc. | PMN |
| Aug 28, 2018 | K181683 | BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc. | PMN |
| Aug 15, 2018 | K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc. | PMN |
| Feb 6, 1997 | K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN Microbiologics, Inc. | JTO |
| Dec 20, 1995 | K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR Microbiologics, Inc. | JTO |
| Aug 24, 1995 | K951889 | LYFO(TM) DIFFERENTIAL DISK Microbiologics, Inc. | JTO |
| May 11, 1995 | K945489 | LYFO(TM) DIFFERENTIAL DISK Microbiologics, Inc. | JSP |
| May 11, 1995 | K945488 | LYFO(TM) DIFFERENTIAL DISK Microbiologics, Inc. | JSP |
| May 11, 1995 | K945487 | LYFO(TM) DIFFERENTIAL DISK Microbiologics, Inc. | JSP |
| Apr 24, 1995 | K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN Microbiologics, Inc. | JTO |
| Apr 24, 1995 | K945882 | LYFO(TM) DIFFERENTIAL DISK-BILE Microbiologics, Inc. | JTO |
| Apr 24, 1995 | K945881 | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK Microbiologics, Inc. | JTO |
| Apr 24, 1995 | K945880 | LYFO(TM) DIFFERENTIAL DISK-SPS Microbiologics, Inc. | JTO |
Latest recalls
| 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 |
| Mar 25, 2025 | Microbiologics Inc Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N Open, Classified |
OHQ | None listed |
| Mar 14, 2025 | Microbiologics Inc Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N Open, Classified |
OHQ | None listed |
| Feb 12, 2025 | Microbiologics Inc Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test Open, Classified |
OHQ | None listed |
| Feb 12, 2025 | Microbiologics Inc Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test Open, Classified |
OHQ | None listed |
| 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 |
| Feb 12, 2024 | Microbiologics Inc Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. Open, Classified |
OHQ | None listed |
| 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 |
| Sep 14, 2022 | Microbiologics Inc 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 Terminated |
OHQ | None listed |
| May 6, 2022 | Microbiologics Inc KWIK-STIK" plus: Clostridium perfringens Terminated |
JTR | K861022 |
| Mar 24, 2022 | Microbiologics Inc Inactivated macrolide and quinolone-resistant Mycoplasma genitalium Terminated |
OHQ | None listed |
| Mar 22, 2022 | Microbiologics Inc Inactivated macrolide-resistant Mycoplasma genitalium Terminated |
OHQ | None listed |
| Mar 3, 2022 | Microbiologics Inc Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing:
Positive Control 1 - Semi-Quantitative Bacteria
Positive Control 2 - Viruses and Atypical Bacteria Terminated |
OHQ | None listed |
| Feb 25, 2022 | Microbiologics Inc Mycoplasma genitalium Control Panel (Inactivated Pellet) Terminated |
OHQ | None listed |
| 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 |
| Aug 20, 2021 | Microbiologics Inc SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. Terminated |
OHQ | None listed |
| Aug 20, 2021 | Microbiologics Inc SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. Terminated |
OHQ | None listed |
| 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 |
| Jan 3, 2020 | Microbiologics Inc Vaginal Verification Panel Ref 8208 Lot 8208-11 Terminated |
OHQ | None listed |
| Dec 16, 2019 | Microbiologics Inc Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180
Used in test systems to estimate test precision and to detect systematic analytical de Terminated |
OHQ | None listed |
| May 16, 2019 | Microbiologics Inc Cepheid Xpert C. difficile/Epi Control Panel Open, Classified |
PMN | K190463 |
| Apr 9, 2019 | Microbiologics Inc Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233
Product Usage:
On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direc Open, Classified |
PMN | None listed |
| Apr 9, 2019 | Microbiologics Inc Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226
Product Usage:
On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US Open, Classified |
PMN | None listed |
| Mar 7, 2019 | Microbiologics Inc Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use Terminated |
PMN | None listed |
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