FDA.reportPublic FDA data

Poly Rb A-Hu Lambda LC

Primary DI
05700572000921
Brand
Poly Rb A-Hu Lambda LC
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
A0193
Device description
Polyclonal Rabbit Anti-Human Lambda Light Chains
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
DEHLAMBDA, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEHLambda, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812662000IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADako Corp.1981-09-29DEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572000921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572000921057005720009215700572000921

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
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
05051700021111Freelite® Human Lambda Free Kit for use on the Roche cobas® c SystemsTHE BINDING SITE GROUP LIMITEDDEH2026-02-02
00817089023505DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
00817089023512DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
00817089023529DiazymeDIAZYME LABORATORIES, INC.DEH2025-10-22
03607360051030FLC LambdaSEBIADEH2023-03-31
03607360051122FLC Control Level 1SEBIADEH2023-03-31
03607360051139FLC Control Level 2SEBIADEH2023-03-31
05051700019873Optilite Freelite Mx Lambda Free KitTHE BINDING SITE GROUP LIMITEDDEH2018-11-16
00630414237473N FLC SUPPLEMENTARY REAGENTSiemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237480N FLC CONTROL SL1Siemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237497N FLC STANDARD SLSiemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414237503N FLC CONTROL SL2Siemens Healthcare Diagnostics Products GmbHDEH2018-10-08
00630414167664N LATEX FLC lambdaSiemens Healthcare Diagnostics Products GmbHDEH2018-01-28
03607360021002CAPILLARYS IMMUNOTYPINGSEBIADEH2018-01-24
03607360023006IT/IF ControlSEBIADEH2018-01-24
03607360026007CAPI 3 IMMUNOTYPINGSEBIADEH2018-01-24
05051700019675Optilite Freelite Lambda Free Bulk KitTHE BINDING SITE GROUP LIMITEDDEH2017-04-25
B1761180antiserum to Human Lambda (free and bound)KENT LABORATORIES INCDEH2016-09-24
05051700006286Freelite® Human Kappa Free Kit for use on the Beckman AU® series THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006392Freelite® Human Lambda Free Kit for use on the Siemens BN™II - Bulk KitTHE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006408Freelite® Human Lambda Free Kit for use on the Beckman AU® series THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006415Freelite® Human Lambda Free Kit for use on the ADVIA® THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006439Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006446Freelite® Human Lambda Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®80THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006460Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra® THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006477Freelite® Human Lambda Free Kit for use on the SPAPLUS THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700006491Freelite® Human Lambda Free Kit for use on the Siemens BN™II THE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700010177Sheep Anti-Human Lambda Free Light Chains Immunofixation GradeTHE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700012102Freelite® Human Lambda Free Kit for use on the Roche cobas® c systemsTHE BINDING SITE GROUP LIMITEDDEH2016-09-24
05051700012201Freelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk KitTHE BINDING SITE GROUP LIMITEDDEH2016-09-24