IMMUNODOT™ RICKETTSIA CONORII 4010

GUDID 00613745000015

The GenBio ImmunoDOT Rickettsia conorii (Mediterranean Spotted Fever) test is a semi-quantitative enzyme immunoassay for the detection of total IgG and IgM antibodies to Rickettsia conorii for the serological confirmation from serum, plasma or heparinized whole blood. This test is intended to be performed by trained medical technologists only.

Genbio

Rickettsia conorii total antibody IVD, kit, immunoblot

• Primary Device ID: 00613745000015
• NIH Device Record Key: 057eb179-2506-4aea-adbe-29bcb77a8bdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMUNODOT™ RICKETTSIA CONORII
• Version Model Number: 800-4010
• Catalog Number: 4010
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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
• 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
• 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
• 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
• 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	00613745000015 [Primary]

FDA Product Code

• LSQ: Reagent, Rickettsia Serological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-31

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