LKTClass I
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Microbiology · 21 CFR 866.3480
MDR events0All time
Recalls0All time
Registered firms11Currently listed
510(k) clearances23All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
510(k) clearances
23 clearances for this product code
- Diagnostic Hybrids, Inc.Dec 23, 2008
K081928 · D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
- Diagnostic Products Corp.Mar 18, 1999
K983336 · PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
- Diagnostic Products Corp.Dec 19, 1994
K943317 · PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
- NeogenexJun 30, 1994
K942173 · RSV ANTIGEN TEST
- Gull Laboratories, Inc.Dec 9, 1991
K912842 · RSV-MAB TEST
- Baxter Diagnostics, Inc.Sep 27, 1991
K912838 · BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
- Vitek Systems, Inc.Sep 23, 1991
K912371 · BIOMERIEUX RSV DIRECT IF KIT
- Bion Ent., Ltd.Oct 16, 1989
K894623 · RESPIRATORY SYNCYTIAL VIRUS