FDA UDI
In Commercial Distribution
🇺🇸 United States
RedLine Alert™ Test
DI: G143TC51230101
·
Model: N/A
·
Tetracore, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- RedLine Alert™ Test
- Primary DI
- G143TC51230101
- Version / Model
- N/A
- Catalog Number
- TC-5123-010
- Company Name
- Tetracore, Inc.
- Labeler DUNS
- 070893032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-06-15
- Public Version
- 2
- Public Version Date
- 2023-04-07
- Public Version Status
- Update
- Public Device Record Key
- e5cc028a-847e-46ef-81ae-0a561a285fec
Device Description
Immunochromatographic test kit for presumptive identification of Bacillus anthracis colonies
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPO | Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody | Microbiology | 866.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50428 | Bacillus anthracis antigen IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Bacillus anthracis 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 used in the laboratory or in point-of-care analyses to detect Bacillus anthracis, the bacteria associated with anthrax. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G143TC51230101 | HIBCC | ||||
| Unit of Use | G143TC51230100 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030370 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius