FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740000493
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1E78-02
Catalog number
01E7802
Device description
Specific Proteins Multiconstituent Calibrator
Published
2016-09-09
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
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
00380740000493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740000493003807400004933807400004930380740000493

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of plasma proteins 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
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
05700572001140Poly Rb A-Hu IgAAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2022-01-27
00380740171711AlinityABBOTT IRELANDCZP2021-04-29
00380740171704ARCHITECTABBOTT IRELANDCZP2021-04-02
00380740175177ARCHITECTAbbott GmbHCZP2020-11-06
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
00380740019754ARCHITECTABBOTT LABORATORIESCZP2016-06-06