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

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
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJT2026-08-13
00893038002944Cholestech LDX™Alere San Diego, Inc.JJT2023-12-20
00380740156381ARCHITECTABBOTT LABORATORIESJJT2020-03-03
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
00847661001225LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661001232LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661002154LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00852553007049Enzymer Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007056Enzymer ER Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
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