FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740175177
Brand
ARCHITECT
Company
Abbott GmbH
Model
9D98-22
Catalog number
09D9822
Device description
Immunoglobulin A
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
CZPIGA, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740175177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740175177003807401751773807401751770380740175177

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) 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
05700572001140Poly Rb A-Hu IgAAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2022-01-27
00380740171711AlinityABBOTT IRELANDCZP2021-04-29
00380740171704ARCHITECTABBOTT IRELANDCZP2021-04-02
03610230007334Yumizen C1200 Immunoglobulin AHORIBA ABX SASCZP2020-07-13
00630414285030N Latex IgASiemens Healthcare Diagnostics Products GmbHCZP2020-06-23
07613336121313Tina-quant IgA Gen.2Roche Diagnostics GmbHCZP2020-03-05
00380740153915AlinityAbbott GmbHCZP2020-01-01
B1761020Antiserum to Human IgA (alpha chain specific)KENT LABORATORIES INCCZP2016-09-24
05051700010375Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk KitTHE BINDING SITE GROUP LIMITEDCZP2016-09-24
05055273203882IgARANDOX LABORATORIES LIMITEDCZP2016-09-24
05055273203899IgARANDOX LABORATORIES LIMITEDCZP2016-09-24
05055273203905IgARANDOX LABORATORIES LIMITEDCZP2016-09-24
00842768007200N Latex IgASiemens Healthcare Diagnostics Products GmbHCZP2016-09-24
04015630913411Immunoglobulin ARoche Diagnostics GmbHCZP2016-09-20
04015630919666Tinaquant IgA Gen2Roche Diagnostics GmbHCZP2016-09-20
04015630919680Tinaquant IgA Gen2Roche Diagnostics GmbHCZP2016-09-20
04015630925728Tinaquant IgA Gen2Roche Diagnostics GmbHCZP2016-09-20
05055273203820IgARANDOX LABORATORIES LIMITEDCZP2016-09-16
05700572000617Poly Rb A-Hu IgAAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2016-09-16
05700572000860Poly Rb A-Hu IgA, IgG, IgMAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2016-09-16
00380740000493ARCHITECTABBOTT LABORATORIESCZP2016-09-09
00380740019754ARCHITECTABBOTT LABORATORIESCZP2016-06-06