FDA UDI
In Commercial Distribution
🇺🇸 United States
Fluoro-Check TM COVID-19 Antigen Test
DI: 00895160002793
·
Model: TF-8150
·
NANO-DITECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Fluoro-Check TM COVID-19 Antigen Test
- Primary DI
- 00895160002793
- Version / Model
- TF-8150
- Company Name
- NANO-DITECH CORPORATION
- Labeler DUNS
- 126544316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-11-25
- Public Version
- 2
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- d13acc36-c719-48dd-908b-bb0a04227b52
Device Description
An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
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
- Yes
- 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 |
|---|---|---|---|---|
| QMN | Covid-19 Multi-Analyte Antigen Device | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10895160002790 | GS1 | ||||
| Primary | 00895160002793 | GS1 |
Customer Contacts
- Phone
- 1-609-406-3300
- [email protected]