FDA UDI
In Commercial Distribution
🇺🇸 United States
OSOM Ultra Flu A&B Controls 5 Test
DI: 00742860100215
·
Model: 1005
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- OSOM Ultra Flu A&B Controls 5 Test
- Primary DI
- 00742860100215
- Version / Model
- 1005
- Catalog Number
- 1005
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-01-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 23b7d9a3-0c47-475a-9724-d28ffd4033f1
Device Description
OSOM Ultra Flu A&B Controls 5 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
- 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 |
|---|---|---|---|---|
| GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | Microbiology | 866.3330 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49121 | Influenza A/B virus antigen 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 antigens from influenza A virus and/or influenza B virus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00742860100215 | GS1 | ||||
| Unit of Use | 10742860100212 | GS1 |