Product code PAB

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
Cytomegalovirus (Cmv) Dna Quantitative Assay
Medical specialty
Microbiology
Device class
2
Regulation number
866.3180
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.

Related Records

Related PMA Records

PMADeviceApplicantDecision date
P110037S051COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2019-11-05
P160041S026cobas CMV TestROCHE MOLECULAR SYSTEMS, INC.2019-10-10
P110037S050Cobas AmpliPrep and Cobas TaqMan CMV TestRoche Molecular Systems, Inc.2019-10-10
P160041S025cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-09-26
P110037S049COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2019-09-12
P160041S024Cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-09-04
P110037S048cobas AmpliPrep/cobas TaqMan CMV TestRoche Molecular Systems, Inc.2019-08-13
P160041S022Cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-06-06
P160041S021Cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-06-06
P160041S020Cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-05-24
P160041S019cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-05-22
P110037S047COBAS® AmliPrep/COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.2019-05-22
P160044S002Abbott RealTime CMVABBOTT MOLECULAR2019-05-15
P160041S018Cobas CMV TestROCHE MOLECULAR SYSTEMS, INC.2019-05-09
P110037S046Cobas AmpliPrep/Cobas TaqMan CMV TestRoche Molecular Systems, Inc.2019-05-09
P160041S017cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-05-03
P110037S045COBAS® AmpliPrep/COBAS TaqMan CV TestRoche Molecular Systems, Inc.2019-04-10
P160041S016cobas CMVROCHE MOLECULAR SYSTEMS, INC.2019-01-02
P110037S044COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2019-01-02
P160041S015cobas CMVROCHE MOLECULAR SYSTEMS, INC.2018-12-13
P110037S043COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2018-12-13
P160041S014cobas CMVROCHE MOLECULAR SYSTEMS, INC.2018-12-07
P110037S042COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2018-12-07
P130027S006artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx KitQIAGEN, INC.2018-09-26
P160041S013cobas CMVROCHE MOLECULAR SYSTEMS, INC.2018-09-19
P110037S041COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2018-09-19
P160041S012cobas CMVROCHE MOLECULAR SYSTEMS, INC.2018-08-17
P110037S040COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2018-08-17
P160041S011Cobas CMVROCHE MOLECULAR SYSTEMS, INC.2018-07-26
P110037S039COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular Systems, Inc.2018-07-26

Related 510(k) Records

510(k)DeviceApplicantDecision date
K252481cobas CMVRoche Molecular Systems, Inc.2025-11-03
K243485Alinity m CMVAbbott Molecular, Inc.2025-07-01
K243935Aptima CMV Quant AssayHologic, Inc.2025-01-17

Related GUDID Devices

Primary DIBrandCompanyPublished
00884999051065Alinity mABBOTT MOLECULAR INC.2024-02-22
15420045514553APTIMAHologic, Inc.2022-06-01
15420045514560APTIMAHologic, Inc.2022-06-01
15420045514577APTIMAHologic, Inc.2022-06-01
15420045514584APTIMAHologic, Inc.2022-06-01
00884999049598Alinity mABBOTT MOLECULAR INC.2022-05-19
00884999049604Alinity mABBOTT MOLECULAR INC.2022-05-19
00884999049611Alinity mABBOTT MOLECULAR INC.2022-05-19
00884999049956Alinity mABBOTT MOLECULAR INC.2022-05-19
00875197006490cobas® CMV Control KitRoche Molecular Systems, Inc.2021-12-10
00875197006421cobas® CMVRoche Molecular Systems, Inc.2021-12-10
04053228024538artus® CMV QS-RGQ MDx KitQIAGEN GmbH2018-05-04
00875197004922cobas CMVRoche Molecular Systems, Inc.2017-07-06
00875197004939cobas CMV Control KitRoche Molecular Systems, Inc.2017-07-06
00884999045774RealTimeABBOTT MOLECULAR INC.2017-06-06
00884999045781RealTimeABBOTT MOLECULAR INC.2017-06-06
00884999045798RealTimeABBOTT MOLECULAR INC.2017-06-06
00884999047297RealTimeABBOTT MOLECULAR INC.2017-06-06
00884999046603RealTimeABBOTT MOLECULAR INC.2017-04-17
04053228002086artus® CMV RGQ MDx KitQIAGEN GmbH2017-01-04
00875197002584COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.2014-09-10