FDA.reportPublic FDA data

SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)

Primary DI
05055273216387
Brand
SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)
Company
RANDOX LABORATORIES LIMITED
Model
SR10345
Catalog number
SR10345
Device description
Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.
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
MJYKit, Serological, Negative Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJYKit, Serological, Negative ControlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273216387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216387050552732163875055273216387

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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05055273200676AMYAY9707AY97072016-09-09
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05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
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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
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00380740131364AlinityAbbott GmbHMJY2020-11-06
00380740011161ARCHITECTAbbott GmbHMJY2016-09-09
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00380740011185ARCHITECTAbbott GmbHMJY2016-09-09