Product code LIN
- Device name
- Antisera, Conjugated Fluorescent, Cytomegalovirus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3175
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2008-06-13 |
| K983762 | NUCLISENS CMV PP67 | Organon Teknika Corp. | 1999-09-15 |
| K991650 | CMV BRITE TURBO KIT | Biotest Diagnostics Corp. | 1999-07-12 |
| K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1996-06-07 |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | Biotest Diagnostics Corp. | 1996-01-30 |
| K934798 | PATHODX CYTOMEGALOVIRUS | Diagnostic Products Corp. | 1994-03-25 |
| K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT | Incstar Corp. | 1992-08-11 |
| K912592 | CMV-EA MAB TEST | Gull Laboratories, Inc. | 1991-12-04 |
| K905257 | OPUS CMV TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-04-17 |
| K904036 | BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN | Baxter Healthcare Corp | 1990-10-16 |
| K894002 | CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY | Baxter Healthcare Corp | 1989-08-10 |
| K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-14 |
| K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1986-05-13 |
| K843138 | CMV TEST | Microbiological Research Corp. | 1985-01-29 |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Immulok, Inc. | 1982-11-01 |
| K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI | Bartels Immunodiagnostic Supplies, Inc. | 1982-05-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04053252507397 | Light Diagnostics CMV DFA Reagent | EMD Millipore Corporation | 2020-04-17 |
| 04053252282089 | Light Diagnostics CMV DFA Reagent | EMD Millipore Corporation | 2020-04-16 |
| 30014613330677 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-20 |
| 05391516745901 | Bartels® | TRINITY BIOTECH PUBLIC LIMITED COMPANY | 2016-09-23 |
| 05391516745888 | Bartels® | TRINITY BIOTECH PUBLIC LIMITED COMPANY | 2016-09-23 |
| 05391516745871 | Bartels® | TRINITY BIOTECH PUBLIC LIMITED COMPANY | 2016-09-23 |
| 05391516745161 | Bartels® | TRINITY BIOTECH PUBLIC LIMITED COMPANY | 2016-09-23 |
| 04053252368745 | Light Diagnostics™ CMV DFA Kit | EMD Millipore Corporation | 2016-09-23 |
| 08717953022349 | CMV Brite™, CMV antigenemia detection kit | IQ Products B.V. | 2016-09-19 |
| 08717953022325 | CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit | IQ Products B.V. | 2016-09-19 |
| 08717953022394 | Reagent E - CMV Brite™ Turbo kit | IQ Products B.V. | 2016-09-19 |
| 08717953022387 | Reagent D - CMV Brite™ Turbo kit | IQ Products B.V. | 2016-09-19 |
| 08717953022370 | Reagent C - CMV Brite™ Turbo kit | IQ Products B.V. | 2016-09-19 |
| 08717953022363 | Reagent B - CMV Brite™ Turbo kit | IQ Products B.V. | 2016-09-19 |
| 08717953022356 | Reagent A - CMV Brite™ Turbo kit | IQ Products B.V. | 2016-09-19 |
| 08717953022318 | CMV Brite™ Turbo Control Slides | IQ Products B.V. | 2016-09-19 |
| 08717953022301 | CMV Brite™ Turbo, CMV antigenemia detection kit | IQ Products B.V. | 2016-09-19 |
| 30014613330660 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |