FDA.reportPublic FDA data

IgA

Primary DI
05055273203882
Brand
IgA
Company
RANDOX LABORATORIES LIMITED
Model
IA3832
Catalog number
IA3832
Device description
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955794000IGA IMMUNOTURBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.1996-04-05CZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273203882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273203882050552732038825055273203882

GMDN Terms#

Term, Definition table
TermDefinition
Immunoglobulin A antibody (anti-IgA) 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 qualitative and/or quantitative detection of antibodies to Immunoglobulin A (anti-IgA) in a clinical specimen.

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
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

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
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