PMA P970025
- Device
- PRO-TRAC II TACROLIMUS ELISA KIT
- Applicant
- DiaSorin, Inc.
- PMA number
- P970025
- Product code
- MLM
- Decision date
- 1999-04-27
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Approval order 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.
Current openFDA PMA Record
- Device
- PRO-TRAC II TACROLIMUS ELISA KIT
- Applicant
- DiaSorin, Inc.
- PMA number
- P970025
- Product code
- MLM
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Decision date
- 1999-04-27
- Decision code
- APRL
- Date received
- 1997-06-30
- Approval order 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.