Company ยท US
Inverness Medical Professional Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2007. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2010 | Inverness Medical Professional Diagnostics UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy. Terminated |
LCX | None listed |
| Sep 25, 2010 | Inverness Medical Professional Diagnostics UCG Slide Test;
Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy. Terminated |
LCX | None listed |
| Mar 13, 2007 | Inverness Medical Professional Diagnostics Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma.
Product No. 61100KVC
10 test devices containing anti D-dimer monoclonal antibod Terminated |
GHH | K993276 |
| Nov 29, 2006 | Inverness Medical Professional Diagnostics NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use
Product Code: 852-000 Terminated |
MJH | K982238 |