FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNODOT™ RICKETTSIA CONORII
DI: 00613745000015
·
Model: 800-4010
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMMUNODOT™ RICKETTSIA CONORII
- Primary DI
- 00613745000015
- Version / Model
- 800-4010
- Catalog Number
- 4010
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-31
- Public Version
- 2
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 057eb179-2506-4aea-adbe-29bcb77a8bdd
Device Description
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.
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 |
|---|---|---|---|---|
| LSQ | Reagent, Rickettsia Serological | Microbiology | 866.3500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51444 | Rickettsia conorii total antibody IVD, kit, immunoblot | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Rickettsia conorii in a clinical specimen using an immunoblot method. The assay is designed to detect infection with Rickettsia conorii, the rickettsial bacteria from the Spotted Fever Group. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745000015 | 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