PMA P930036S007

Device: ADVIA CENTAUR IMMUNOASSAY
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S007
Product code: LOK
Decision date: 2017-04-26
Classification: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval for wetcake manufacturing process changes to the ADVIA Centaur AFP Solid Phase reagent to achieve the current hook specification of >1,000 ng/mL with an AFP containing sample that is between 1,000,000 to 1,150,000 ng/mL.

Current openFDA PMA Record#

Device: ADVIA CENTAUR IMMUNOASSAY
Applicant: Siemens Healthcare Diagnostics, Inc.
PMA number: P930036
Supplement: S007
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2017-04-26
Decision code: APPR
Date received: 2016-10-20
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for wetcake manufacturing process changes to the ADVIA Centaur AFP Solid Phase reagent to achieve the current hook specification of >1,000 ng/mL with an AFP containing sample that is between 1,000,000 to 1,150,000 ng/mL.