FDA.report

ARCHITECT

Primary DI
00380740161828
Brand
ARCHITECT
Company
Abbott GmbH & Co. KG
Model
8G63-22
Catalog number
08G6322
Device description
Direct Bilirubin
Published
2020-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CIGDIAZO COLORIMETRY, BILIRUBIN

Product Code Classifications

CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740161828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740161828003807401618283807401618280380740161828

GMDN Terms

TermDefinition
Conjugated (direct) bilirubin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
315786293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00380740170325Alinity09P553A09P553A2020-03-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336235508Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-02-04
07613336235515Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
07613336235522Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
00630414313429Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313436Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00380740167578ARCHITECTABBOTT IRELANDCIG2024-08-15
04015630924912Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
04015630927531Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
10673486001204Teco Diagnostics Direct Bilirubin TC-MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001211Teco Diagnostics Direct Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001280Teco Diagnostics Total Bilirubin TC MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001297Teco Diagnostics Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001303Teco Diagnostics Direct and Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
00811727015952Pointe Total Bilirubin ReagentPOINTE SCIENTIFIC, INC.CIG2021-01-30
00811727016133Pointe Direct Bilirubin ReagentPOINTE SCIENTIFIC, INC.CIG2021-01-30
00811727016256Pointe Total Bilirubin ReagentPOINTE SCIENTIFIC, INC.CIG2021-01-30
03610230006870Yumizen C1200 Direct BilirubinHORIBA ABX SASCIG2020-08-28
03610230006887Yumizen C1200 Total BilirubinHORIBA ABX SASCIG2020-08-28
00811727015822Pointe Direct Bilirubin for BS480HORIBA INSTRUMENTS INCORPORATEDCIG2020-05-28
00380740174965ARCHITECTAbbott GmbH & Co. KGCIG2020-04-12
00380740174972ARCHITECTAbbott GmbH & Co. KGCIG2020-04-12
07613336164884Direct BilirubinRoche Diagnostics GmbHCIG2020-03-13
07613336121061Bilirubin Direct Gen.2Roche Diagnostics GmbHCIG2020-03-05
07613336121078Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2020-03-05
00386100002039TBIL Reagent KitMEDICA CORPORATIONCIG2019-02-14
00386100002084DBIL Reagent Kit MEDICA CORPORATIONCIG2019-02-14
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00380740158422AlinityAbbott GmbH & Co. KGCIG2019-01-02
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSCIG2018-09-21
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