Exact Diagnostics
Exact Diagnostics COVFLU SARS-CoV-2, Flu and RSV Positive Run Control is a molecular quality-control material used with compatible assays. Its formulated targets let a laboratory check that…
Exact Diagnostics COVFLU SARS-CoV-2, Flu and RSV Positive Run Control is a molecular quality-control material used with compatible assays. Its formulated targets let a laboratory check that an assay run detects its intended viral targets; it is control material, not a patient specimen or diagnostic result.
The manufacturer’s control documentation describes whole-organism SARS-CoV-2, influenza A, influenza B and RSV-A targets in a synthetic matrix with human genomic DNA. The human DNA component simulates adequate specimen sampling, while the viral targets provide the positive control content.
Listed Item
SARS-CoV-2, Flu, RSV Positive Run Control
Control Composition and Pack
Exact Diagnostics describes the COVFLU positive run control as five 1.0 mL vials. Its quality-control material is used alongside molecular testing to monitor assay performance and support consistency between runs or lots. The named targets and matrix distinguish this control from a clinical sample and from a patient-facing diagnostic test.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
Record
| Listed by | Exact Diagnostics, United States |
|---|---|
| FDA product code | OHQ |
| Device type | Multi-Analyte Controls Unassayed |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-12 |
| Record revised | 2023-12-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to -20 °C |
| Distribution end date | 2021-08-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RPNEG | In distribution | |
| HIVH102 | In distribution | |
| BRTRC | In distribution | |
| HCVH102 | In distribution | |
| B19L101 | In distribution | |
| NEGSYN | In distribution | |
| VZVL101 | In distribution | |
| BORRC | In distribution | |
| COV019CE | In distribution | |
| B19H102 | In distribution | |
| CTNGP200 | In distribution | |
| ADVH102 | In distribution | |
| HBVLOD | In distribution | |
| EVRC | In distribution | |
| HBVH102 | In distribution | |
| CDFP200 | In distribution | |
| MRSAP200 | In distribution | |
| NEG000 | In distribution | |
| NEG050 | In distribution | |
| JCVH102 | In distribution | |
| NEGSTI | In distribution | |
| HPVP200 | In distribution | |
| RPPOS | In distribution | |
| JCVL101 | In distribution | |
| COV000CE | In distribution | |
| HSVP200 | In distribution | |
| HSV2H102 | In distribution | |
| NEGHAI | In distribution | |
| COVFLU | In distribution | |
| HV6H102 | In distribution | |
| ADVL101 | In distribution | |
| HBVL101 | In distribution | |
| HSV2L101 | In distribution | |
| CMVLOD | In distribution | |
| VZVH102 | In distribution | |
| CTNGRC | In distribution | |
| ZKVH102 | In distribution | |
| HV6L101 | In distribution | |
| HIVL101 | In distribution | |
| HPV16C | In distribution | |
| 12020069 | In distribution | |
| ANARC | In distribution | |
| 12020068 | In distribution | |
| HCVLOD | In distribution | |
| CMVH102 | In distribution | |
| EBVH102 | In distribution | |
| CMVL101 | In distribution | |
| CTNGPOS | In distribution | |
| HSV1L101 | In distribution | |
| HSV1H102 | In distribution | |
| COVFLUNEG | In distribution | |
| ZKVL101 | In distribution | |
| BABRC | In distribution | |
| BKVL101 | In distribution | |
| HPV18C | In distribution | |
| HCVL101 | In distribution | |
| HPV68C | In distribution | |
| HIVLOD | In distribution | |
| EBVL101 | In distribution | |
| ERLRC | In distribution | |
| BKVH102 | In distribution | |
| HPVNEG | In distribution | |
| 12019432 | In distribution | |
| RPRC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NATtrol™ | Zeptometrix LLC. | 54 |
| QC Sets and Panels: Helix Elite™ | Microbiologics, Inc. | 51 |
| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 41 |
| Multichem S Plus | Techno-Path Manufacturing Ltd. | 35 |
| Virotrol | Bio-Rad Laboratories Inc. | 27 |
| Helix Elite™ Molecular Standards: Synthetic Standard | Microbiologics, Inc. | 25 |
| Multichem IA Plus | Techno-Path Manufacturing Ltd. | 17 |
| D3 | Diagnostic Hybrids, Inc. | 14 |
| Liquichek | Bio-Rad Laboratories Inc. | 10 |
| Multichem IA | Techno-Path Manufacturing Ltd. | 8 |
| QC Sets and Panels: Kwik-Stik™ 2 Pack | Microbiologics, Inc. | 8 |
| QC Sets and Panels: Kwik-Stik™ | Microbiologics, Inc. | 7 |
Showing 12 of 107. All products under Multi-Analyte Controls Unassayed
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.