FDA.reportPublic FDA data

ImmunoDOT Borrelia Test

Primary DI
00613745050256
Brand
ImmunoDOT Borrelia Test
Company
GenBio
Model
800-5025
Catalog number
5025
Device description
The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSRReagent, Borrelia Serological Reagent

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911627000IMMUNODOT BORRELIA (LYME) TESTGeneral Biometrics, Inc.1992-04-08LSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613745050256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613745050256006137450502566137450502560613745050256

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi total antibody IVD, kit, immunoblotA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
858-592-9300support@genbio.com

Regulatory Flags#

DUNS number
940425333
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00613745003887NGSgo®-LibrX End Prep Enzyme200200512026-05-06
00613745003894NGSgo®-LibrX End Prep Buffer200200522026-05-06
00613745003900NGSgo®-LibrX Ligase Mix200200532026-05-06
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