Fort Worth Diagnostics BABDIA
Fort Worth Diagnostics BABDIA is a babesia microti nucleic acid IVD (FDA Class I; FDA product code JJX, Single (Specified) Analyte Controls (Assayed And Unassayed)) made by Fort Worth Diagnostics LLC, listed in FDA GUDID since 27 Oct 2026 (UDI-DI 00810227730174), registry data as of 9 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810227730174 | Date27 Oct 2026 | StatusListed |
Official records
- AccessGUDID record 00810227730174
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Fort Worth Diagnostics
- Generic name
- Babesia microti nucleic acid IVD, control
- Model / Ref / Catalog
- BABDIA
- Primary DI / UDI-DI
- 00810227730174
- FDA product code
- JJX
- GMDN term
- Babesia microti nucleic acid IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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