FDA.reportPublic FDA data

ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents

Primary DI
00630414513058
Brand
ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10341113
Catalog number
2188064
Device description
Bilirubin Total - 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
MQMBILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFMEnzymatic Method, BilirubinClinical Chemistry2
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063845000
K170065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063845000ADVIA CHEMISTRY TOTAL BILIRUBIN_2Bayer Healthcare, LLC2007-12-07JFM
K170065000ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.2017-03-09JFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414513058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414513058006304145130586304145130580630414513058

GMDN Terms#

Term, Definition table
TermDefinition
Total bilirubin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total bilirubin in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius35 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
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05055273214796DIRECT BILIRUBIN 2 (D BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
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05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSMQM2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSMQM2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSMQM2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSMQM2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSMQM2018-09-21
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSMQM2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSMQM2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSMQM2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSMQM2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSMQM2018-09-21
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