FDA.reportPublic FDA data

SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3)

Primary DI
05055273215694
Brand
SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3)
Company
RANDOX LABORATORIES LIMITED
Model
PS10223
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273215694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273215694050552732156945055273215694

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry protein IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336235546PreciControl HIV Gen IIRoche Diagnostics GmbHJJY2026-05-22
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05391523442572Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442589Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442596Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442602Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442619Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442626Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
03701700819400ELITROL IVITALSCIENTIFICJJY2026-03-04
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07333066024035EliA IgM Calibrator WellPhadia ABJJY2026-01-29
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05430003908532LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908549LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908556LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908563SEEKER®Lacar MDX TechnologiesJJY2026-01-15
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00884883009349MAS Omni•IMMUNE PRO Max, Level 1Microgenics CorporationJJY2025-08-12
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