FDA.reportPublic FDA data

Dimension CardioPhase high sensitivity CRP Flex reagent cartridge

Primary DI
00842768016028
Brand
Dimension CardioPhase high sensitivity CRP Flex reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10444897
Catalog number
RF434
Device description
CardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 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
NQDCARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053109000DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGEDade Behring, Inc.2005-12-23NQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768016028PrimaryGS10
00630414003887Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768016028008427680160288427680160280842768016028
00630414003887006304140038876304140038870630414003887

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of C-reactive protein (CRP) in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

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00630414611075Atellica CH Crea311537215115372152026-05-08
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00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
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00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
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00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414305028Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
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00380740158491ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00380740158507ARCHITECTABBOTT LABORATORIESNQD2018-12-28
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