FDA UDI
In Commercial Distribution
🇺🇸 United States
OSOM COVID-19 Antigen Rapid Test
DI: 00742860000027
·
Model: 1066-40
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
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Basic Information
- Brand Name
- OSOM COVID-19 Antigen Rapid Test
- Primary DI
- 00742860000027
- Version / Model
- 1066-40
- Catalog Number
- 1066-40
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2024-12-16
- Public Version
- 1
- Public Version Date
- 2024-12-24
- Public Version Status
- New
- Public Device Record Key
- a15a3e00-dac4-4b58-8b08-f245771ad5c1
Device Description
OSOM COVID-19 Antigen Rapid 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QKP | Coronavirus Antigen Detection Test System. | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64787 | SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. 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 | 00742860000027 | GS1 | ||||
| Unit of Use | 10742860000024 | GS1 |