Panels › Microbiology › Product code LIN · Class 2
Antisera, Conjugated Fluorescent, Cytomegalovirus
Regulation 866.3175
0510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LIN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2008 | K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT Diagnostic Hybrids, Inc. | LIN |
| Sep 15, 1999 | K983762 | NUCLISENS CMV PP67 Organon Teknika Corp. | LIN |
| Jul 12, 1999 | K991650 | CMV BRITE TURBO KIT Biotest Diagnostics Corp. | LIN |
| Jun 7, 1996 | K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | LIN |
| Jan 30, 1996 | K951550 | CMV BRITE ANTIGENEMIA TEST KIT Biotest Diagnostics Corp. | LIN |
| Mar 25, 1994 | K934798 | PATHODX CYTOMEGALOVIRUS Diagnostic Products Corp. | LIN |
| Aug 11, 1992 | K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT Incstar Corp. | LIN |
| Dec 4, 1991 | K912592 | CMV-EA MAB TEST Gull Laboratories, Inc. | LIN |
| Apr 17, 1991 | K905257 | OPUS CMV TEST SYSTEM Pb Diagnostic Systems, Inc. | LIN |
| Oct 16, 1990 | K904036 | BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN Baxter Healthcare Corp | LIN |
| Aug 10, 1989 | K894002 | CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY Baxter Healthcare Corp | LIN |
| Jul 14, 1989 | K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) Immuno Concepts, Inc. | LIN |
| Jul 14, 1989 | K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) Immuno Concepts, Inc. | LIN |
| May 13, 1986 | K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT Bartels Immunodiagnostic Supplies, Inc. | LIN |
| Jan 29, 1985 | K843138 | CMV TEST Microbiological Research Corp. | LIN |
| Nov 1, 1982 | K822606 | CYTOMEGALOVIRUS ANTOBODY IGG Immulok, Inc. | LIN |
| May 3, 1982 | K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI Bartels Immunodiagnostic Supplies, Inc. | LIN |
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