FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740169909
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
09D9924
Catalog number
09D9924
Device description
Immunoglobulin G 388 tests
Published
2021-04-02
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
DEWIGG, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740169909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740169909003807401699093807401699090380740169909

GMDN Terms#

Term, Definition table
TermDefinition
Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 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
989964119
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740169893AlinityABBOTT IRELANDDEW2021-04-29
00380740175184ARCHITECTAbbott GmbHDEW2020-11-06
00630414002903BN II SystemSiemens Healthcare Diagnostics Products GmbHDEW2020-09-24
03610230007358Yumizen C1200 Immunoglobulin GHORIBA ABX SASDEW2020-07-13
07613336121320Tina-quant IgG Gen.2Roche Diagnostics GmbHDEW2020-03-05
00380740153922AlinityAbbott GmbHDEW2019-12-24
03573026619527VIDAS® PC SOFTWARE V4.9BIOMERIEUX SADEW2019-12-20
05055273203967IgGRANDOX LABORATORIES LIMITEDDEW2019-06-03
00842768012167N Cuvette Segments for BN IISiemens Healthcare Diagnostics Products GmbHDEW2017-11-15
00842768012174N Predilution WellsSiemens Healthcare Diagnostics Products GmbHDEW2017-10-31
B1761010Antiserum to Human IgG (gamma chain specific)KENT LABORATORIES INCDEW2016-09-24
05051700010368Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010443Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05055273203936IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203950IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203974IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
00840733101304MERIFLUOR GullSORB MERIDIAN BIOSCIENCE, INC.DEW2016-09-23
04015630913923IGG Immunoglobulin G Turbidimetric)Roche Diagnostics GmbHDEW2016-09-20
04015630919697Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630919710Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630925735Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
05700572000273Poly Rb a Hu Alpha-1-AntitrypsinAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572000860Poly Rb A-Hu IgA, IgG, IgMAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572001386Poly Rb A-Hu IgGAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
00816426020108K-ASSAY® IgG ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEW2016-09-16