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
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
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