FDA.reportPublic FDA data

FRUCTOSAMINE (FRUC)

Primary DI
05055273208733
Brand
FRUCTOSAMINE (FRUC)
Company
RANDOX LABORATORIES LIMITED
Model
FR4030
Catalog number
FR4030
Published
2019-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110188000DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KITDiazyme Laboratories2011-05-17LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273208733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273208733050552732087335055273208733

GMDN Terms#

Term, Definition table
TermDefinition
Fructosamine IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
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