PMA P010021S026
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S026
- Product code
- MZO
- Decision date
- 2015-07-23
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S026
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2015-07-23
- Decision code
- OK30
- Date received
- 2015-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.