FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge C4

Primary DI
00842768005237
Brand
Dimension® Flex® reagent cartridge C4
Company
Siemens Healthcare Diagnostics Inc.
Model
10444981
Catalog number
DF102
Device description
Complement C4 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
DBICOMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBIComplement C4, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994293000DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.2000-03-01DBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005237PrimaryGS10
00630414004570Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005237008427680052378427680052370842768005237
00630414004570006304140045706304140045700630414004570

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C4/C4c IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen, using a nephelometry/turbidimetry 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170196AlinityABBOTT IRELANDDBI2021-05-13
00380740170202ARCHITECTABBOTT IRELANDDBI2021-03-19
00380740175160ARCHITECTAbbott GmbHDBI2020-11-06
07613336133606Tina-quant Complement C4 Ver.2Roche Diagnostics GmbHDBI2020-03-05
00380740150679AlinityAbbott GmbHDBI2019-06-27
00630414595658Atellica CH C4Siemens Healthcare Diagnostics Inc.DBI2017-12-27
15099590010577AUBeckman Coulter, Inc.DBI2016-09-24
B1761090Antiserum to Human C-4 (b1e)KENT LABORATORIES INCDBI2016-09-24
B1761092Anti Human Complement C4 (b1e) FITCKENT LABORATORIES INCDBI2016-09-24
05051700015585Human C4 Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDBI2016-09-24
05051700017602Optilite C4 KitTHE BINDING SITE GROUP LIMITEDDBI2016-09-24
00842768006067Dimension Vista® C4 Complement Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00842768009693N Antiserum to Human C4Siemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00842768009709N Antiserum to Human C4Siemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 ReagentsSiemens Healthcare Diagnostics Inc.DBI2016-09-24
04015630910267Tinaquant C4Roche Diagnostics GmbHDBI2016-09-20
04015630917716Tinaquant Complement C4 ver2Roche Diagnostics GmbHDBI2016-09-20
04015630928460Tinaquant Complement C4 ver2Roche Diagnostics GmbHDBI2016-09-20
05055273201628C4RANDOX LABORATORIES LIMITEDDBI2016-09-16
05700572002420Poly Rb A-Hu C4c Complement/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDBI2016-09-16
00816426020085K-ASSAY® Complement C4 ReagentKAMIYA BIOMEDICAL COMPANY, LLCDBI2016-09-16
00817302020939CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635CAROLINA LIQUID CHEMISTRIES CORPORATIONDBI2016-09-01
15099590229726SynchronBeckman Coulter, Inc.DBI2016-08-24
15099590230449IMMAGEBeckman Coulter, Inc.DBI2016-08-24
10758750006854VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DBI2016-08-23
00380740019747ARCHITECTABBOTT LABORATORIESDBI2016-06-06