FDA.reportPublic FDA data

PMA P920048S013

Device
Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
Applicant
Hologic, Inc.
Product code
LKV
Decision date
2020-01-28
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement
Approval for a new supplier of a critical component, A137 ascites, that is used in the manufacture of Rapid fFN for the TLiIQ System and Fetal Fibronectin Enzyme Immunoassay.

Current openFDA PMA Record#

Device
Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S013
Product code
LKV
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date
2020-01-28
Decision code
APPR
Date received
2018-01-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a new supplier of a critical component, A137 ascites, that is used in the manufacture of Rapid fFN for the TLiIQ System and Fetal Fibronectin Enzyme Immunoassay.