FDA.reportPublic FDA data

Atellica CH DBil_2

Primary DI
00630414595801
Brand
Atellica CH DBil_2
Company
Siemens Healthcare Diagnostics Inc.
Model
11097532
Catalog number
11097532
Device description
Direct Bilirubin (Dbil_2) Atellica CH - RGT 1792T
Published
2017-12-26
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
JFMENZYMATIC METHOD, BILIRUBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFMEnzymatic Method, BilirubinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053132000WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc.2005-12-30JFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414595801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414595801006304145958016304145958010630414595801

GMDN Terms#

Term, Definition table
TermDefinition
Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of conjugated (direct) bilirubin 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(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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055273214772TOTAL BILIRUBIN 2 (T BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
05055273214796DIRECT BILIRUBIN 2 (D BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
00630414595818Atellica CH TBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-21
00630414513058ADVIA® Chemistry Total Bilirubin_2 TBIL_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513065ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513072ADVIA® Chemistry TBIL_2 Total Bilirubin_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513089ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00657498000564Direct Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498000588Total Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498001486Sirrus® Total Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498001493Sirrus® Direct Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
05055273208306T BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208313D BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208320D BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208337T BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
15099590222642SynchronBeckman Coulter, Inc.JFM2016-08-24