FDA.reportPublic FDA data

CalSet CK-MB

Primary DI
04015630939534
Brand
CalSet CK-MB
Company
Roche Diagnostics GmbH
Model
07394667190
Catalog number
07394667190
Published
2017-04-17
Public version status
Update
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
JHYCOLORIMETRIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHYColorimetric Method, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132571000ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche Diagnostics2013-10-18JHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630939534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630939534040156309395344015630939534

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) 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
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870020655CK-MB AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JHY2019-02-11
00816870020662CK-MB AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JHY2019-02-11
00816870022338Monobind AccuLite CKMB CLIA Kit - 96 WellsMONOBIND, INC.JHY2019-02-11
00816870022345CK-MB AccuLite CLIA Test System - 192 WellsMONOBIND, INC.JHY2019-02-11
04015630939978Elecsys CK-MBRoche Diagnostics GmbHJHY2017-04-21
M525552612SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATIONJHY2017-02-10
15099590011468AUBeckman Coulter, Inc.JHY2016-09-24
00842768013829Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.JHY2016-09-24
00842768013898Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.JHY2016-09-24
00842768015328Dimension Vista® Flex® reagent cartridge MMBSiemens Healthcare Diagnostics Inc.JHY2016-09-24
04015630928729Elecsys CKMB STAT CalSetRoche Diagnostics GmbHJHY2016-09-20
04015630934638Elecsys CKMB STAT ImmunoassayRoche Diagnostics GmbHJHY2016-09-20
04015630934621Elecsys CKMB ImmunoassayRoche Diagnostics GmbHJHY2016-09-20
M5255516740Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255517650Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255520150SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255520280SPIFE CK Reagent KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255523960QuickGel CK Vis Gel KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255525890Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255525900Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07