FDA.reportPublic FDA data

cobas 8000 Core Unit

Primary DI
04015630928330
Brand
cobas 8000 Core Unit
Company
Roche Diagnostics GmbH
Model
05641446001
Catalog number
05641446001
Published
2015-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630928330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630928330040156309283304015630928330

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23
07613336218402Elecsys LH09755721190097557211902026-02-19
07613336236499Elecsys BRAHMS PCT10456299190104562991902026-02-19
04015630911707Elecsys Myoglobin STAT CalSet11820893122118208931222016-09-20
04015630918805Cfas PUC3121305122031213051222016-09-20
04015630919932C.f.a.s. PAC3555941190035559411902016-09-20
04015630936373Cfas Proteins11355279160113552791602016-09-20
04015630939060Elecsys Myoglobin Immunoassay12178214160121782141602016-09-20
04015630939114Elecsys BRAHMS PCT505688820050568882002016-09-20
04015630940073Elecsys BRAHMS PCT07301715190073017151902017-04-21
07613336224281PreciControl Rubella IgG09966625190099666251902026-01-28
07613336206737VENTANA DP 600 slide scanner09311360001093113600012025-12-15
07613336232125Ionify Steroids 109629645160096296451602025-12-11
07613336232132Ionify Steroids 209634444160096344441602025-12-11
07613336216958CalSet Phospho-Tau (181P) Plasma09697896190096978961902025-11-18
07613336216965PreciControl Phospho-Tau (181P) Plasma09697926190096979261902025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
00380740225155ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740225162ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740223748AlinityAbbott GmbHJJE2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740224530ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740186241AlinityAbbott GmbHJJE2025-12-19
00380740186258AlinityAbbott GmbHJJE2025-12-19
00380740213398AlinityAbbott GmbHJJE2025-12-19
00380740213404AlinityAbbott GmbHJJE2025-12-19
00380740213411AlinityAbbott GmbHJJE2025-12-19
00380740213428AlinityAbbott GmbHJJE2025-12-19
00380740199074AlinityAbbott GmbHJJE2025-11-27
00380740215224AlinityAbbott GmbHJJE2025-09-29
04260678680010GEMINISTRATEC SEJJE2025-09-05
00380740220556ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220563ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220495ARCHITECTABBOTT LABORATORIESJJE2025-08-02
00380740220501ARCHITECTABBOTT LABORATORIESJJE2025-08-02
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586426P780 Clinical Chemistry AnalyzerDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-06-13
10758750035656VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JJE2025-05-21
03701700860358Viva-ProEVitalScientific B.V.JJE2025-04-30
15999883586744Atellica DT 250 Analyzer Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-04-30
00380740186425AlinityAbbott GmbHJJE2025-04-15
00380740190644ARCHITECTABBOTT LABORATORIESJJE2025-04-15