FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740019693
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
9D91-21
Catalog number
09D9121
Device description
Haptoglobin
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DADHAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DADHaptoglobin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740019693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740019693003807400196933807400196930380740019693

GMDN Terms#

Term, Definition table
TermDefinition
Haptoglobin 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 haptoglobin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414610986Atellica CH HAPT2Siemens Healthcare Diagnostics Inc.DAD2023-08-28
00630414305080Atellica CH HAPT2Siemens Healthcare Diagnostics Inc.DAD2023-08-28
00380740169879AlinityABBOTT IRELANDDAD2021-05-13
00380740169886ARCHITECTABBOTT IRELANDDAD2021-03-19
07613336140772Tina-quant Haptoglobin ver.2Roche Diagnostics GmbHDAD2020-03-05
00380740150686AlinityAbbott GmbHDAD2019-07-08
05055273203806HAPTOGLOBIN (HP)RANDOX LABORATORIES LIMITEDDAD2019-06-03
06970291985161Haptoglobin Kit (Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.DAD2019-03-07
00630414210827Atellica™ CH HaptSiemens Healthcare Diagnostics Inc.DAD2018-12-08
15099590010621AUBeckman Coulter, Inc.DAD2016-09-24
B1761120Antiserum to Human HaptoglobinKENT LABORATORIES INCDAD2016-09-24
05051700016094Human Haptoglobin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDAD2016-09-24
05051700017626Optilite Haptoglobin KitTHE BINDING SITE GROUP LIMITEDDAD2016-09-24
00842768006111DImension Vista® Haptoglobin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDAD2016-09-24
00630414491356ADVIA® Chemistry HAPT Haptoglobin ReagentsSiemens Healthcare Diagnostics Inc.DAD2016-09-24
00630414506005ADVIA® Chemistry HAPT Haptoglobin ReagentsSiemens Healthcare Diagnostics Inc.DAD2016-09-24
04015630906765Tinaquant HaptoglobinRoche Diagnostics GmbHDAD2016-09-20
04015630916580Tinaquant Haptoglobin ver2Roche Diagnostics GmbHDAD2016-09-20
04015630928620Tinaquant Haptoglobin ver2Roche Diagnostics GmbHDAD2016-09-20
00816426020153K-ASSAY® Haptoglobin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDAD2016-09-16
10758750002283VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DAD2016-08-26
15099590224431SynchronBeckman Coulter, Inc.DAD2016-08-24
15099590230456IMMAGEBeckman Coulter, Inc.DAD2016-08-24