FDA.reportPublic FDA data

Poly Rb A-Hu Albumin/FITC

Primary DI
05700572002390
Brand
Poly Rb A-Hu Albumin/FITC
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
F0117
Device description
Polyclonal Rabbit Anti-Human Albumin/FITC
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
DDZALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDZAlbumin, Fitc, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831902000FLUORESCEIN CONJUGATED IMMUNOGLOBIN-Dako Corp.1983-07-18DDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572002390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572002390057005720023905700572002390

GMDN Terms#

Term, Definition table
TermDefinition
Albumin 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 albumin 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
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
05055273209242MICROALBUMIN (mALB)RANDOX LABORATORIES LIMITEDDDZ2019-06-03
00852169008270ClearChem Diagnostics Inc. MicroAlbuminCLEARCHEM DIAGNOSTICS INC.DDZ2018-05-22
05055273204551mALBRANDOX LABORATORIES LIMITEDDDZ2016-09-24
05055273204568mALBRANDOX LABORATORIES LIMITEDDDZ2016-09-24
05055273209259mALBRANDOX LABORATORIES LIMITEDDDZ2016-09-24
B1761142Anti Human Albumin FITCKENT LABORATORIES INCDDZ2016-09-21
05055273204537mALBRANDOX LABORATORIES LIMITEDDDZ2016-09-16
05055273204544mALBRANDOX LABORATORIES LIMITEDDDZ2016-09-16
00811727011886Pointe Scientific, Inc. MicroalbuminHORIBA INSTRUMENTS INCORPORATEDDDZ2016-08-31