FDA.reportPublic FDA data

CalCheck ISD

Primary DI
04015630947126
Brand
CalCheck ISD
Company
Roche Diagnostics GmbH
Model
06441955190
Catalog number
06441955190
Published
2019-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJTEnzyme controls (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJTEnzyme Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630947126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630947126040156309471264015630947126

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunosuppressant therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740156398ARCHITECTABBOTT LABORATORIESJJT2020-03-03
04015630947119PreciControl ISDRoche Diagnostics GmbHJJT2019-01-14
00380740044831ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00380740045593ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00856743007024Cardiac Control MarkerMORE DIAGNOSTICS INCJJT2018-03-31
00856743007031Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00856743007048Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00893038002524Alere Cholestech LDX®Alere San Diego, Inc.JJT2018-03-30
00856743007017Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-30
M52551340CK/LD Isoenzyme Control (5 x 2 mL)HELENA LABORATORIES CORPORATIONJJT2017-03-17
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00847661001232LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661002154LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
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00852553007131Enzymer ER Verifier, Level GVERICHEM LABORATORIES, INC.JJT2016-11-29
00725609000205SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000212SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000441SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000458SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00384840518902Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJT2016-09-22
00038481518505Prodigy AutoCode Blood Glucose Monitoring SystemPRODIGY DIABETES CARE, LLCJJT2016-09-22