Identity
- Trade Name
- RedLine Alert™ Test FDA UDI
- Generic Name
- Bacillus anthracis antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Immunochromatographic test kit for presumptive identification of Bacillus anthracis colonies FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Immunochromatographic test kit for presumptive identification of Bacillus anthracis colonies FDA UDI
Identifiers
- Catalog Number
- TC-5123-010 FDA UDI
- Primary DI / UDI-DI
- G143TC51230101 FDA UDI
- 510(k) Number
- K030370 FDA UDI
- FDA Product Code
- NPO FDA UDI
- GMDN Term
- Bacillus anthracis antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bacillus anthracis antigen IVD, kit, rapid ICT, clinical
RedLine Alert™ Test by Tetracore, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bacillus anthracis antigen IVD, kit, rapid ICT, clinical.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tetracore, Inc.
Sources (1)
- FDA UDI e5cc028a-847e-46ef-81ae-0a561a285fec 36 fields · synced Jun 6, 2026