FDA.reportPublic FDA data

Atellica IM CKMB

Primary DI
00630414598574
Brand
Atellica IM CKMB
Company
Siemens Healthcare Diagnostics Inc.
Model
10995530
Catalog number
10995530
Device description
CKMB - Atellica IM - RGT 100T
Published
2017-12-22
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
00630414598574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598574006304145985746304145985740630414598574

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24
00630414177038ADVIA Centaur® TSH10309959103099592016-09-24
00630414556093ADVIA Centaur® SHBG Calibrator10285318102853182016-09-24
00630414559704ADVIA Centaur® T3 MCM10361928103619282016-09-24
00630414574516ADVIA® Chemistry Hemoglobin A1c_3 Calibrators10491408104914082016-09-24
00630414579160ADVIA Centaur® iPTH10492369104923692016-09-24
00630414585345ADVIA Centaur® iPTH10493615104936152016-09-24
00630414585352ADVIA Centaur® iPTH10493616104936162016-09-24
00630414587486ADVIA Centaur® iPTH Calibrator10630628106306282016-09-24
00630414587882ADVIA Centaur® Systems VitD Calibrator10630911106309112016-09-24
00630414600611ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents10916067109160672016-09-24
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27

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
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
00630414177434ADVIA Centaur® CKMBSiemens 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