FDA.reportPublic FDA data

SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)

Primary DI
05055273216394
Brand
SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)
Company
RANDOX LABORATORIES LIMITED
Model
SR10346
Catalog number
SR10346
Device description
Lyme Disease Positive Control is intended for use with in vitro assays, for determination of IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. Lyme Disease Positive Control is unassayed without target values and is suitable for use on many analysers.
Published
2020-01-22
Public version status
New
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
MJXKit, Serological, Positive Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJXKit, Serological, Positive ControlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273216394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216394050552732163945055273216394

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.

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
+442894422413technical.services@randox.com

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
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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJX2024-03-15
00840733103476RSV Positive ControlMERIDIAN BIOSCIENCE, INC.MJX2021-06-18
00380740131364AlinityAbbott GmbHMJX2020-11-06
10758750001149VITROSORTHO CLINICAL DIAGNOSTICSMJX2020-04-01
00816784020413ACCURUN®Lgc Clinical Diagnostics, Inc.MJX2018-09-24
00380740011161ARCHITECTAbbott GmbHMJX2016-09-09
00380740011178ARCHITECTAbbott GmbHMJX2016-09-09
00380740011185ARCHITECTAbbott GmbHMJX2016-09-09