PRO-TRAC II TACROLIMUS ELISA KIT
FDA premarket approval P970025 · decided 1999-04-27
Approval details
- PMA number
- P970025
- Trade name
- PRO-TRAC II TACROLIMUS ELISA KIT
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Applicant
- DiaSorin, Inc.
- Date received
- 1997-06-30
- Decision date
- 1999-04-27
- Days to decision
- 666 days
- Decision code
- APRL
- Product code
- MLM
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for PRO-Trac(TM) II Tacrolimus ELISA Kit. This device is indicated for the quantitative determination of tacrolimus ELISA Kit. This device indicated for the quantitative determination of tacrolimus (Prograf(R) FK506) and some metabolites in EDTA or heparinized human whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
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