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
05700572005971Mono Mo A-Hu Beta-Amyloid Cl 6F/3DM08722020-09-17
05700572033028DakoGA6332026-05-15
05700572033127DakoGA6142026-05-16
05700572033363DakoGA6282026-05-15
05700572034230DakoGA6272026-05-16
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209M07582020-09-17
05700574035631Alissa InterpretK5849AA2022-07-11
05700572027799Poly Rb A-Hu Alpha-1-FetoproteinA00082020-09-17
05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
05700571112182DakoGC1182025-09-02
05700575013812Dako Omnis DI Water Filling AccessoriesGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareGC1222025-06-25
05700575014031Dako Omnis Waste Tank (NHz)GC1262025-06-25
05700575014048Dako Omnis Waste Tank (Hz)GC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)GC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)GC1242025-06-25
05700572007340Poly Rb A-Hu IgG/HRPP02142016-09-16

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