ImmunoDOT Borrelia Test 5025

GUDID 00613745050256

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.

Genbio

Borrelia burgdorferi total antibody IVD, kit, immunoblot
Primary Device ID00613745050256
NIH Device Record Keyc1fa7f40-d80b-40a7-816e-cd63fd7183d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoDOT Borrelia Test
Version Model Number800-5025
Catalog Number5025
Company DUNS940425333
Company NameGenbio
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-592-9300
Emailsupport@genbio.com
Phone858-592-9300
Emailsupport@genbio.com
Phone858-592-9300
Emailsupport@genbio.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613745050256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSRReagent, Borrelia Serological Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Genbio

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00613745000152 - ImmunoDOT Leptospira IgM2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp
00613745000169 - ImmunoDOT Leptospira IgM2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp
00613745010052 - ImmunoFA 10x PBS2018-07-06 10-fold concentrate of 0.01M PBS
00613745010069 - ImmunoFA 10x PBS2018-07-06 10-fold concentrate of 0.01M PBS
00613745010250 - ImmunoFA Mounting Fluid2018-07-06 Mounting fluid for use with ImmunoFA kits.
00613745012001 - ImmunoFA Toxoplasma IgG2018-07-06 The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii
00613745012018 - ImmunoFA Toxoplasma Slides2018-07-06 Toxoplasma Slides for use with ImmunoFA Toxoplasma kits

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