FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNODOT™ Rickettsia Typhi
DI: 00613745000022
·
Model: 800-4020
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMMUNODOT™ Rickettsia Typhi
- Primary DI
- 00613745000022
- Version / Model
- 800-4020
- Catalog Number
- 4020
- 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
- 3614b0e5-2385-44d9-8a28-fb1b17c60a12
Device Description
The GenBio R. typhi (murine typhus) test is a semi-quantitative enzyme immunoassay for the detection of IgG and IgM antibodies to Rickettsia typhi as an aid in the presumptive diagnosis of murine typhus from serum, heparinized plasma or heparinized whole blood. This test is to be performed by trained medical personnel 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 |
|---|---|---|---|---|
| 51508 | Rickettsia typhi 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 typhi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Rickettsia typhi, the rickettsial bacteria associated with endemic typhus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745000022 | 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