FDA UDI
In Commercial Distribution
🇺🇸 United States
Status™ COVID-19/Flu Control
DI: 10743816001614
·
Model: BSP-511C-00
·
PRINCETON BIOMEDITECH CORPORATION
Product Codes
0
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Status™ COVID-19/Flu Control
- Primary DI
- 10743816001614
- Version / Model
- BSP-511C-00
- Catalog Number
- BSP-511C-00
- Company Name
- PRINCETON BIOMEDITECH CORPORATION
- Labeler DUNS
- 362917692
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- a18e0056-b32a-475a-a418-34dcb369049a
Device Description
Status™ COVID-19/Flu A&B Control Swab Kit (5 Positive/ 5 Negative)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 64788 | SARS-CoV-2 immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen. | No | Active |
| 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 | 10743816001614 | GS1 |
Customer Contacts
- Phone
- 800-526-2125
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius