FDA.reportPublic FDA data

cobas U Calibration Strip

Primary DI
04015630932276
Brand
cobas U Calibration Strip
Company
Roche Diagnostics GmbH
Model
06390579001
Catalog number
06390579001
Published
2019-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JIXCalibrator, multi-analyte mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630932276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630932276040156309322764015630932276

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10673486014013Teco Diagnostics Chemistry CalibratorTECO DIAGNOSTICSJIX2026-03-20
03701700817802ELICAL 2 VITALSCIENTIFICJIX2026-03-04
05430003908648SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908655SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908662SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908679SEEKER®Lacar MDX TechnologiesJIX2026-01-15
04250317554994Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2025-07-31
07613336232156Ionify CalSet Steroids and Vitamin DRoche Diagnostics GmbHJIX2025-06-25
00850053916267IDG/SanzayIDG/SANZAY CorporationJIX2024-07-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
08430793040907Aptiva® APS IgM CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414304915Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
04580262010314Calibrator 2TOKYO BOEKI MEDISYS INC.JIX2023-12-18
08430793040181Aptiva® CTD Essential CalibratorsINOVA DIAGNOSTICS, INC.JIX2023-12-14
00816776020544MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020568MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020582MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020599MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
10852676007060Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
00811403011087CO2 Alkaline BufferDiamond Diagnostics Inc.JIX2023-06-05
00816776020247MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-12-22
00817302024494CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024500CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024517CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00380740164973ARCHITECTABBOTT IRELANDJIX2022-07-12
00380740164980AlinityABBOTT IRELANDJIX2022-07-12
04250317551115Urine Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-07-08
04250317552365Saliva Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-06-21
00816776020513MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05
00816776020537MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05