FDA.reportPublic FDA data

IgE CAL SET

Primary DI
05055273203912
Brand
IgE CAL SET
Company
RANDOX LABORATORIES LIMITED
Model
IE2492
Catalog number
IE2492
Device description
This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
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
DGCIge, Antigen, Antiserum, Control

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010855000RANDOX IGERandox Laboratories, Ltd.2001-05-15DGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273203912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273203912050552732039125055273203912

GMDN Terms#

Term, Definition table
TermDefinition
Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of immunoglobulin E (IgE) antibodies to multiple specific protein allergens and/or total immunoglobulin E (IgE total) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00After reconstitution, the material is stable for 4 weeks at +2°C to +8°C.
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
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
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15099590701727Total Immunoglobulin E (IgE)Beckman Coulter, Inc.DGC2022-05-03
00840239017888Immunoglobulin E (IgE) ELISADRG International IncDGC2021-06-07
00380740156282ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156367ARCHITECTABBOTT LABORATORIESDGC2020-03-03
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07333066000206ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066000220ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066000367ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066019512ImmunoCAP Total IgE CalibratorsPhadia ABDGC2019-03-26
07333066019529ImmunoCAP Total IgE Curve ControlsPhadia ABDGC2019-03-26
07333066019642ImmunoCAP Total IgE Control LMHPhadia ABDGC2019-03-26
07333066019673ImmunoCAP Total IgEPhadia ABDGC2019-03-26
00816870020242IgE AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2019-02-11
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