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)
Top companies in OHQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Microbiologics Inc | 0 | 19 |
| TECHNO-PATH MANUFACTURING LTD. | 0 | 5 |
| Randox Laboratories Ltd. | 0 | 2 |
| Biomerieux Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 3, REF:AE623X Open, Classified |
OHQ | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 2
REF: AE622X Open, Classified |
OHQ | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 1
REF:AE621X Open, Classified |
OHQ | None listed |
| Nov 14, 2025 | TECHNO-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 |
OHQ | None listed |
| Nov 14, 2025 | TECHNO-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 |
OHQ | None listed |
| 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 |
| Feb 12, 2024 | Microbiologics Inc Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. Open, Classified |
OHQ | None listed |
| Jan 2, 2024 | Randox 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 |
OHQ | None listed |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706 Open, Classified |
OHQ | None listed |
| Sep 19, 2022 | Randox 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 |
OHQ | None listed |
| 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 |
| 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 |
| 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 |
| 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 |
| Jun 6, 2017 | Microbiologics Inc Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus Terminated |
OHQ | None listed |
| Jun 6, 2017 | Microbiologics Inc Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071. Terminated |
OHQ | None listed |
| Jun 6, 2017 | Microbiologics 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 |
OHQ | None listed |
| Jun 6, 2017 | Microbiologics Inc Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls. Terminated |
OHQ | None listed |
| Jun 6, 2017 | Microbiologics 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 |
OHQ | None listed |
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