Company ยท US
BD Diagnostics (GeneOhm Sciences, Inc)
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2009. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | BD Diagnostics (GeneOhm Sciences, Inc) BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit).
For the rapid detection of methicillin resistant MRSA DNA in nasal specimen. Terminated |
NQX | K042357 |
| Oct 31, 2008 | BD Diagnostics (GeneOhm Sciences, Inc) BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) t Terminated |
NQX | K042357 |
| Oct 31, 2008 | BD Diagnostics (GeneOhm Sciences, Inc) BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) Terminated |
NQX | K042357 |