Search Results
Found 1 results
510(k) Data Aggregation
K Number
K980314Device Name
FETAL D TECTION KIT
Manufacturer
BIOPOOL INTL., INC.
Date Cleared
1998-04-08
(71 days)
Product Code
LIM
Regulation Number
864.7455Why did this record match?
Product Code :
LIM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.
Device Description
Not Found
Ask a Question
Page 1 of 1