FDA.reportPublic FDA data

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

Primary DI
05700572002468
Brand
Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/FITC
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
F0200
Device description
Polyclonal Rabbit Anti-Human IgA, IgG, IgM, Kappa, Lambda/FITC
Published
2017-01-05
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
CZNIga, Fitc, Antigen, Antiserum, Control
DEOKAPPA, FITC, ANTIGEN, ANTISERUM, CONTROL
DESLambda, Fitc, Antigen, Antiserum, Control
DFSIgm, Fitc, Antigen, Antiserum, Control
DGKIgg, Fitc, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZNIga, Fitc, Antigen, Antiserum, ControlImmunology2
DEOKappa, Fitc, Antigen, Antiserum, ControlImmunology2
DESLambda, Fitc, Antigen, Antiserum, ControlImmunology2
DFSIgm, Fitc, Antigen, Antiserum, ControlImmunology2
DGKIgg, Fitc, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572002468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572002468057005720024685700572002468

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
Special Storage Condition, Specify00Keep away from sunlight
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
M52594230IFE Free Lambda Light Chain AntiserumHELENA LABORATORIES CORPORATIONCZN2024-09-27
M52594220IFE Free Kappa Light Chain AntiserumHELENA LABORATORIES CORPORATIONCZN2024-09-27
B1761032Anti Human IgM FITCKENT LABORATORIES INCDFS2016-09-24
B1761172Anti Human Kappa FITCKENT LABORATORIES INCDEO2016-09-24
B1761182Anti Human Lambda FITCKENT LABORATORIES INCDES2016-09-24
B1761012Anti Human IgG FITCKENT LABORATORIES INCDGK2016-09-21
B1761022Anti Human IgA FITCKENT LABORATORIES INCCZN2016-09-21
05700572002444Poly Rb A-Hu Kappa LC/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEO2016-09-16
05700572002451Poly Rb A-Hu Lambda LC/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDES2016-09-16
05700572002505Poly Rb A-Hu IgG/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDGK2016-09-16
05700572002529Poly Rb A-Hu IgM/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDFS2016-09-16
05700572002543Poly Rb A-Hu IgA/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZN2016-09-16
M52594120IFE Free Kappa Light Chain AntiserumHELENA LABORATORIES CORPORATIONCZN2016-09-07
M52594130IFE Free Lambda Light Chain AntiserumHELENA LABORATORIES CORPORATIONCZN2016-09-07