FDA UDI
In Commercial Distribution
🇺🇸 United States
CorDx Tyfast
DI: 00850042559673
·
Model: ACT21003-2B
·
CORETESTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- CorDx Tyfast
- Primary DI
- 00850042559673
- Version / Model
- ACT21003-2B
- Company Name
- CORETESTS, INC.
- Labeler DUNS
- 036440919
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-09-04
- Public Version
- 1
- Public Version Date
- 2024-09-12
- Public Version Status
- New
- Public Device Record Key
- 7499e0bf-39be-416a-bc59-11b49a03a4c7
Device Description
CorDx Tyfast COVID-19 Ag Rapid Test
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 |
|---|---|---|---|---|
| QYT | Over-The-Counter Covid-19 Antigen Test | Microbiology | 866.3984 | 2 |
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 | 00850042559642 | GS1 | ||||
| Primary | 00850042559673 | GS1 | ||||
| Package | 10850042559670 | GS1 | 90 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240728 | 000 |