FDA.reportPublic FDA data

cobas 8800 System

Primary DI
04015630935390
Brand
cobas 8800 System
Company
Roche Diagnostics GmbH
Model
05412722001
Catalog number
05412722001
Published
2017-04-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MZPASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630935390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630935390040156309353904015630935390

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999050860Alinity mABBOTT MOLECULAR INC.MZP2023-08-18
00875197006391cobas® HCVRoche Molecular Systems, Inc.MZP2021-12-10
00884999047761Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999047822Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999047839Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999048652Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999037472RealTimeABBOTT MOLECULAR INC.MZP2017-12-15
04015630935406cobas 6800 SystemRoche Diagnostics GmbHMZP2017-04-20
15420045506787Aptima®Hologic, Inc.MZP2017-03-08
15420045506794Aptima®Hologic, Inc.MZP2017-03-08
15420045506800Aptima®Hologic, Inc.MZP2017-03-08
00884999042681RealTimeABBOTT MOLECULAR INC.MZP2016-07-28
00875197004472cobas omni Wash Reagent WASH)Roche Diagnostics GmbHMZP2015-12-04
00875197004489cobas omni Specimen Diluent SPEC DIL)Roche Diagnostics GmbHMZP2015-12-04
00875197004496cobas omni Lysis Reagent LYS)Roche Diagnostics GmbHMZP2015-12-04
00875197004502cobas omni MGP Reagent MGP)Roche Diagnostics GmbHMZP2015-12-04
00875197004694cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 SystemRoche Diagnostics GmbHMZP2015-12-04
00875197004748cobas® HBV/HCV/HIV-1 Control KitRoche Diagnostics GmbHMZP2015-12-04
00875197005127cobas® NHP Negative Control KitRoche Diagnostics GmbHMZP2015-12-04
00884999000698RealTimeABBOTT MOLECULAR INC.MZP2014-12-01
00884999000704RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999000711RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999000728RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999037434RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999037656RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00630414472386VERSANT® HCV RNA 3.0 ASSAY bDNASiemens Healthcare Diagnostics Inc.MZP2014-09-24
00630414472393VERSANT® HCV RNA 3.0 ASSAY bDNASiemens Healthcare Diagnostics Inc.MZP2014-09-24
00875197004182COBAS® TaqMan® HCV Test For Use With the High Pure SystemRoche Molecular Systems, Inc.MZP2014-09-10
00875197001983COBAS® AmpliPrep/ COBAS® TaqMan® HCV TestRoche Molecular Systems, Inc.MZP2014-09-09
00875197003611COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0Roche Molecular Systems, Inc.MZP2014-09-09