FDA.reportPublic FDA data

Anti-Borrelia VlsE1/pepC10 IgG/IgM

Primary DI
00845533002950
Brand
Anti-Borrelia VlsE1/pepC10 IgG/IgM
Company
ZEUS SCIENTIFIC, INC.
Model
PF-SM3Z9661
Catalog number
PF-SM3Z9661
Device description
The Anti-Borrelia VlsE1/pepC10 IgG/IgM is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
Published
2026-02-18
Public version status
New
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
LSRReagent, Borrelia Serological Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSRReagent, Borrelia Serological ReagentMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533002950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533002950008455330029508455330029500845533002950

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080953946
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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