FDA UDI
In Commercial Distribution
🇺🇸 United States
Status™ COVID-19 Antigen Rapid Test for Home Use
DI: 10743816001638
·
Model: BSP-512-02-00
·
PRINCETON BIOMEDITECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Status™ COVID-19 Antigen Rapid Test for Home Use
- Primary DI
- 10743816001638
- Version / Model
- BSP-512-02-00
- Catalog Number
- BSP-512-02-00
- Company Name
- PRINCETON BIOMEDITECH CORPORATION
- Labeler DUNS
- 362917692
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-20
- Public Version
- 1
- Public Version Date
- 2023-10-30
- Public Version Status
- New
- Public Device Record Key
- 08ad9ad0-3776-4fca-b7e6-419c00d87187
Device Description
Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 65454 | SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing | 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 intended to be used for self-testing by a layperson in the home or similar environment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10743816001638 | GS1 |
Customer Contacts
- Phone
- 1-800-526-2125
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius