FDA UDI
In Commercial Distribution
🇺🇸 United States
Exact Diagnostics
DI: 00812242030918
·
Model: COVFLUNEG
·
EXACT DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Exact Diagnostics
- Primary DI
- 00812242030918
- Version / Model
- COVFLUNEG
- Catalog Number
- COVFLUNEG
- Company Name
- EXACT DIAGNOSTICS, LLC
- Labeler DUNS
- 079898166
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-17
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 4432da77-18aa-42cf-8687-412fea0449cc
Device Description
SARS-CoV-2, Flu, RSV Negative Run Control
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47920 | Multiple-genus respiratory virus nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812242030918 | GS1 |
Customer Contacts
- Phone
- 1-800-424-6723
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -20 Degrees Celsius