ImmunoDOT Leptospira IgM 4030

GUDID 00613745000046

The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.

Genbio

Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00613745000046
• NIH Device Record Key: 16ef00ea-e84b-455a-976a-b9d26e086137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoDOT Leptospira IgM
• Version Model Number: 800-4030
• Catalog Number: 4030
• Company DUNS: 940425333
• Company Name: Genbio
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002024

FDA Product Code

• GRY: Antigens, All, Leptospira Spp.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ImmunoDOT Leptospira IgM]

• 00613745000169: The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically d
• 00613745000152: The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically d
• 00613745000046: The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically d