FDA.reportPublic FDA data

Elecsys CK-MB

Primary DI
04015630939978
Brand
Elecsys CK-MB
Company
Roche Diagnostics GmbH
Model
07027087190
Catalog number
07027087190
Published
2017-04-21
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
04015630939978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630939978040156309399784015630939978

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using a chemiluminescent immunoassay method.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
04015630939534CalSet CK-MBRoche Diagnostics GmbHJHY2017-04-17
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