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Panels › Clinical Chemistry › Product code OHQ · Class 1

Multi-Analyte Controls Unassayed

Regulation 862.1660

0510(k)s in 12 months (0 all time)
5recalls in 12 months (27 all time)
0recalls that name a 510(k)
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Top companies in OHQ

DateFirm and productCodeLinked 510(k)
Oct 22, 2026TECHNO-PATH MANUFACTURING LTD.
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
Open, Classified
OHQNone listed
Oct 22, 2026TECHNO-PATH MANUFACTURING LTD.
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
Open, Classified
OHQNone listed
Oct 22, 2026TECHNO-PATH MANUFACTURING LTD.
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
Open, Classified
OHQNone listed
Nov 14, 2025TECHNO-PATH MANUFACTURING LTD.
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of an
Open, Classified
OHQNone listed
Nov 14, 2025TECHNO-PATH MANUFACTURING LTD.
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determinatio
Open, Classified
OHQNone listed
Mar 25, 2025Microbiologics Inc
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Open, Classified
OHQNone listed
Mar 14, 2025Microbiologics Inc
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Open, Classified
OHQNone listed
Feb 12, 2025Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Open, Classified
OHQNone listed
Feb 12, 2025Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Open, Classified
OHQNone listed
Feb 12, 2024Microbiologics Inc
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Open, Classified
OHQNone listed
Jan 2, 2024Randox Laboratories Ltd.
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxopla
Open, Classified
OHQNone listed
Jan 4, 2023Biomerieux Inc
VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
Open, Classified
OHQNone listed
Sep 19, 2022Randox Laboratories Ltd.
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is de
Terminated
OHQNone listed
Sep 14, 2022Microbiologics 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
OHQNone listed
Mar 24, 2022Microbiologics Inc
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Terminated
OHQNone listed
Mar 22, 2022Microbiologics Inc
Inactivated macrolide-resistant Mycoplasma genitalium
Terminated
OHQNone listed
Mar 3, 2022Microbiologics 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
OHQNone listed
Feb 25, 2022Microbiologics Inc
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Terminated
OHQNone listed
Aug 20, 2021Microbiologics 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
OHQNone listed
Aug 20, 2021Microbiologics 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
OHQNone listed
Jan 3, 2020Microbiologics Inc
Vaginal Verification Panel Ref 8208 Lot 8208-11
Terminated
OHQNone listed
Dec 16, 2019Microbiologics 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
OHQNone listed
Jun 6, 2017Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Terminated
OHQNone listed
Jun 6, 2017Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Terminated
OHQNone listed
Jun 6, 2017Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2C-25C thro
Terminated
OHQNone listed
Jun 6, 2017Microbiologics Inc
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Terminated
OHQNone listed
Jun 6, 2017Microbiologics Inc
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium de
Terminated
OHQNone listed

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