FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740175184
Brand
ARCHITECT
Company
Abbott GmbH
Model
9D99-22
Catalog number
09D9922
Device description
Immunoglobulin G
Published
2020-11-06
Public version status
Update
Distribution status
Not 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
00380740175184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740175184003807401751843807401751840380740175184

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
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
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740169893AlinityABBOTT IRELANDDEW2021-04-29
00380740169909ARCHITECTABBOTT IRELANDDEW2021-04-02
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