GMPClass II
Antisera, Control For Nontreponemal Tests
Microbiology · 21 CFR 866.3820
MDR events1All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances9All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Ampcor Diagnostics, Inc.Jul 6, 1998
K980638 · ADI SYPHILIS RPR LIQUID CONTROLS
- Consolidated Technologies, Inc.Aug 8, 1996
K961998 · QUALITROL SYPHSERO CONTROL SET
- Remel, L.P.Jul 30, 1996
K955143 · RPR LIQUID CONTROLS
- Allelix Diagnostics, Inc.Mar 15, 1989
K885298 · VISUWELL REAGIN TEST 960 TEST KIT
- Texas Immunology, Inc.Feb 4, 1988
K875180 · V-TREND RPRL CARD TEST
- Ncs Diagnostics, Inc.Aug 19, 1985
K851504 · VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
- Biokit USA, Inc.Oct 25, 1984
K843741 · RPR TEST REDITEST
- Beckman Instruments, Inc.Sep 23, 1981
K812425 · BECKMAN R.PR CONTROL SERUM SET