FDA UDI
In Commercial Distribution
🇺🇸 United States
OSOM Flu SARS-CoV-2 Combo Test
DI: 00742860000065
·
Model: 1080
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
27
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Basic Information
- Brand Name
- OSOM Flu SARS-CoV-2 Combo Test
- Primary DI
- 00742860000065
- Version / Model
- 1080
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 27
- Record Status
- Published
- Publish Date
- 2024-12-16
- Public Version
- 2
- Public Version Date
- 2025-12-23
- Public Version Status
- Update
- Public Device Record Key
- a740cd9c-fbbb-4e8b-bc58-23340106ee02
Device Description
OSOM Flu SARS-CoV-2 Combo Test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64770 | Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses and/or adenoviruses. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00742860000065 | GS1 | ||||
| Unit of Use | 10742860000062 | GS1 | ||||
| Package | 50742860100661 | GS1 | 1 | Not in Commercial Distribution | 2025-12-12 |