FDA.reportPublic FDA data

ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents

Primary DI
00630414513065
Brand
ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10341114
Catalog number
2188390
Device description
Bilirubin Direct - ADVIA Chem. - RGT - 4x672 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
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
00630414513065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414513065006304145130656304145130650630414513065

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
Special Storage Condition, Specify00Do not freeze
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
05055273214772TOTAL BILIRUBIN 2 (T BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
05055273214796DIRECT BILIRUBIN 2 (D BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
00630414595801Atellica CH DBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-26
00630414595818Atellica CH TBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-21
00630414513058ADVIA® Chemistry Total Bilirubin_2 TBIL_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