FDA.reportPublic FDA data

mALB

Primary DI
05055273204537
Brand
mALB
Company
RANDOX LABORATORIES LIMITED
Model
MA2423
Catalog number
MA2423
Device description
The product is intended to be used for the quantitative in vitro determination of Microalbumin in urine.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K002674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002674000RANDOX MICROALBUMINRandox Laboratories, Ltd.2000-10-05DDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273204537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273204537050552732045375055273204537

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using a nephelometry/turbidimetry method.

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
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

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
05055273204544mALBRANDOX LABORATORIES LIMITEDDDZ2016-09-16
05700572002390Poly Rb A-Hu Albumin/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDDZ2016-09-16
00811727011886Pointe Scientific, Inc. MicroalbuminHORIBA INSTRUMENTS INCORPORATEDDDZ2016-08-31