IMMUNODOT™ COXIELLA BURNETII (Q FEVER) 4050

GUDID 00613745000039

The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens and is used as an aid in the diagnosis of C. burnetii (Q fever) infection. The test is used as an aid for diagnosis of C. burnetii (Q fever) infection in subjects suspected with consistent signs and symptoms to suspect the infection.

Genbio

Coxiella burnetii total antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00613745000039
• NIH Device Record Key: 13202341-d05d-4b8e-8f16-d91fc5606e4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMUNODOT™ COXIELLA BURNETII (Q FEVER)
• Version Model Number: 800-4050
• Catalog Number: 4050
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745000039 [Primary]

FDA Product Code

• GPJ: Antiserum, Fluorescent, Q Fever

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: 2025-09-09
• Device Publish Date: 2025-09-01

Devices Manufactured by Genbio

• 00613745000039 - IMMUNODOT™ COXIELLA BURNETII (Q FEVER): 2025-09-09The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens and is used as an aid in the diagnosis of C. burnetii (Q fever) infection. The test is used as an aid for diagnosis of C. burnetii (Q fever) infection in subjects suspected with consistent signs and symptoms to suspect the infection.
• 00613745000039 - IMMUNODOT™ COXIELLA BURNETII (Q FEVER): 2025-09-09 The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens
• 00613745000015 - IMMUNODOT™ RICKETTSIA CONORII: 2025-09-08 The GenBio ImmunoDOT Rickettsia conorii (Mediterranean Spotted Fever) test is a semi-quantitative enzyme immunoassay for the det
• 00613745000022 - IMMUNODOT™ Rickettsia Typhi: 2025-09-08 The GenBio R. typhi (murine typhus) test is a semi-quantitative enzyme immunoassay for the detection of IgG and IgM antibodies t
• 00613745000060 - IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test: 2025-09-08 ImmunoFLOW Mycoplasma pneumoniae IgM Test detects human IgM to the complement-fixing antigen and is intended as an aid in the di
• 00613745002231 - IMMUNOWELL JCV IgG Test: 2025-09-08 The ImmunoWELL JCV IgG Test is intended for the qualitative detection of antibodies to JC Virus in human serum. The assay is int
• 00613745031200 - ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST: 2025-09-08 ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) Test is a semi–quantitative or qualitative determination of IgG antibodies in
• 00613745031309 - ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST: 2025-09-08 ImmunoWELL Mycoplasma Pneumoniae Antibody (IgM) Test is a qualitative enzyme immunoassay (EIA) for the detection of specific IgM
• 00613745000046 - ImmunoDOT Leptospira IgM: 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp