FDA.reportPublic FDA data

Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/HRP

Primary DI
05700572007319
Brand
Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/HRP
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
P0212
Device description
Polyclonal Rabbit Anti-Human IgA, IgG, IgM, Kappa, Lambda/HRP
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CZLIGA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DAAIGG, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DEPLAMBDA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DEYIGM, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DFDKappa, Peroxidase, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZLIga, Peroxidase, Antigen, Antiserum, ControlImmunology2
DAAIgg, Peroxidase, Antigen, Antiserum, ControlImmunology2
DEPLambda, Peroxidase, Antigen, Antiserum, ControlImmunology2
DEYIgm, Peroxidase, Antigen, Antiserum, ControlImmunology2
DFDKappa, Peroxidase, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572007319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572007319057005720073195700572007319

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain immunoglobulin IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of kappa and/or lambda light chain immunoglobulins in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

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
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700572515890Mono Mo A-Hu CD34 Class III/FITC Cl BIRMA-K3F70812020-09-17
05700572005049Mono Mo A-Rb Immunoglobulins Cl MR12/53M07372020-09-17
05700572005339Mono Mo A-Hu Amyloid A Cl mc1M07592020-09-17
05700572006428Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7M70722020-09-17
05700572005100Mono Mo A-Hu CD45R0 Cl UCHL1M07422016-09-16
05700572005599Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJM07922020-09-17
05700572006305Mono Mo A-Cytokeratin 17 Cl E3M70462020-09-17
05700572018735Ig Reagent Rb F(ab')2/APCX09982020-09-17
05700572024613Mono Mo A-Hu CD22/APC Cl 4KB128C72812020-09-17
05700572024774Mono Mo a Hu CD61, Platelet Glycoprotein IIIa/APC, Cl Y2/51C72802020-09-17
05700572033929Mono Mo a Hu CD45R0/RPE, Cl UCHL1R08432020-09-17
05700572033936Mono Mo a Hu CD3/PB, Cl UCHT1PB9822020-09-17
05700572033950Mono Mo a Hu CD8/PB, Cl DK25PB9842020-09-17
05700572515258Mono Mo a Hu CD41, Platelet Glycoprotein IIb/RPE, Cl 5B12R70582020-09-17
05700572515432Mono Mo a Hu CD79ß/RPE, Cl SN8R72722020-09-17
05700572515715Mono Mo A-Hu CD7/FITC Cl DK24F07892020-09-17
05700572515746Mono Mo A-Hu CD25, Interleukin-2 Receptor/FITC Cl ACT-1F08012020-09-17
05700572516255Mono Mo a Hu CD5/RPE, Cl DK23R08422020-09-17
05700572516279Mono Mo a Hu CD14/RPE, Cl TÜK4R08642020-09-17
05700572516309Mono Mo a Hu CD16, Fc Gamma Receptor III/RPE, Cl DJ130cR70122020-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594729394CARDINAL HEALTHCardinal Health 200, LLCDAA2023-07-24
50195594729392CARDINAL HEALTHCardinal Health 200, LLCDAA2023-07-24
B1761018Peroxidase conjugated Antiserum to Human IgGKENT LABORATORIES INCDAA2016-09-24
B1761028Peroxidase conjugated antiserum to Human IgAKENT LABORATORIES INCCZL2016-09-24
B1761038Peroxidase conjugated antiserum to Human IgMKENT LABORATORIES INCDEY2016-09-24
05700572007340Poly Rb A-Hu IgG/HRPAGILENT TECHNOLOGIES SINGAPORE PTE LTDDAA2016-09-16
05700572007364Poly Rb A-Hu IgM/HRPAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEY2016-09-16
05700572007388Poly Rb A-Hu IgA/HRPAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZL2016-09-16