FDA.reportPublic FDA data

ADVIA Centaur® CKMB

Primary DI
00630414177434
Brand
ADVIA Centaur® CKMB
Company
Siemens Healthcare Diagnostics Inc.
Model
10309982
Catalog number
110773
Device description
CKMB Mass - CENTAUR - RGT - 100 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHSDIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHSDifferential Rate Kinetic Method, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962126000ACS CKMB II IMMUNOASSAYCiba Corning Diagnostics Corp.1996-06-21JHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414177434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414177434006304141774346304141774340630414177434

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
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414293592Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2020-05-31
00630414294148Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2020-05-31
10758750005123VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2020-04-18
10758750005154VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2020-04-18
07613336121122Creatine KinaseRoche Diagnostics GmbHJHS2020-03-05
00630414598598Atellica IM CKMB CalibratorSiemens Healthcare Diagnostics Inc.JHS2018-02-06
00630414598604Atellica IM CKMB DILSiemens Healthcare Diagnostics Inc.JHS2018-02-06
00630414598581Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2017-12-27
00630414598574Atellica IM CKMBSiemens Healthcare Diagnostics Inc.JHS2017-12-22
04015630940813Creatine KinaseRoche Diagnostics GmbHJHS2016-12-12
00842768025525Dimension® Flex® reagent cartridge CKISiemens Healthcare Diagnostics Inc.JHS2016-09-24
00842768027918Dimension Vista® Flex® reagent cartridge MBISiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414124803ADVIA Centaur® Systems, ACS:180® Systems CKMB CalibratorSiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414175324ADVIA Centaur® CKMB DiluentSiemens Healthcare Diagnostics Inc.JHS2016-09-24
00630414177441ADVIA Centaur® CKMBSiemens Healthcare Diagnostics Inc.JHS2016-09-24
04015630940806Creatine KinaseRoche Diagnostics GmbHJHS2016-09-20
04015630921041CKL Creatine KinaseRoche Diagnostics GmbHJHS2016-09-20
04015630921058Creatine KinaseMBRoche Diagnostics GmbHJHS2016-09-20
04015630926831Creatine KinaseMBRoche Diagnostics GmbHJHS2016-09-20
04015630926909Creatine kinaseRoche Diagnostics GmbHJHS2016-09-20
08058056680297CKMB UDRSENTINEL CH. SPAJHS2016-09-16
10758750004201VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2016-08-23
10758750004294VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JHS2016-08-23