FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNODOT™ COXIELLA BURNETII (Q FEVER)
DI: 00613745000039
·
Model: 800-4050
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMUNODOT™ COXIELLA BURNETII (Q FEVER)
- Primary DI
- 00613745000039
- Version / Model
- 800-4050
- Catalog Number
- 4050
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 2
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 13202341-d05d-4b8e-8f16-d91fc5606e4b
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GPJ | Antiserum, Fluorescent, Q Fever | Microbiology | 866.3500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51364 | Coxiella burnetii total antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Coxiella burnetii in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Coxiella burnetii, the rickettsial bacteria associated with Q fever. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745000039 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 25 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius