PMA P070006S004
- Device
- T-SPOT .TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S004
- Product code
- OJN
- Decision date
- 2010-03-19
- Classification
- Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Approval order statement
- ADDITION OF AN EXTRA APPROVED SUPPLIER (US BIOLOGICAL, INC.) OF PHYTOHEMAGGLUTININ AND OF ANOTHER SUPPLIER (THERMO FISHER SCIENTIFIC GMBH) OF ANTIGEN PEPTIDES (PANELS A AND B) FOR THE T-SPOT®.TB KITS.
Current openFDA PMA Record#
- Device
- T-SPOT .TB TEST
- Applicant
- Oxford Immunotec, Ltd.
- PMA number
- P070006
- Supplement
- S004
- Product code
- OJN
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Decision date
- 2010-03-19
- Decision code
- OK30
- Date received
- 2010-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN EXTRA APPROVED SUPPLIER (US BIOLOGICAL, INC.) OF PHYTOHEMAGGLUTININ AND OF ANOTHER SUPPLIER (THERMO FISHER SCIENTIFIC GMBH) OF ANTIGEN PEPTIDES (PANELS A AND B) FOR THE T-SPOT®.TB KITS.