PMA P970054S008
- Device
- BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S008
- Product code
- MYL
- Decision date
- 2010-03-19
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Approval order statement
- INTRODUCTION OF A NEW PRODUCTION PROCEDURE TO PREPARE A VIRAL MASTER STOCK, AND THE DOCUMENTATION OF THE TUBING PRIMING STEPS FOR THE PLATE COATING EQUIPMENT USED IN THE DEVICE.
Current openFDA PMA Record#
- Device
- BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S008
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2010-03-19
- Decision code
- OK30
- Date received
- 2010-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INTRODUCTION OF A NEW PRODUCTION PROCEDURE TO PREPARE A VIRAL MASTER STOCK, AND THE DOCUMENTATION OF THE TUBING PRIMING STEPS FOR THE PLATE COATING EQUIPMENT USED IN THE DEVICE.