FDA UDI
In Commercial Distribution
🇺🇸 United States
CHORUS Q FEVER PHASE II IgG
DI: 08033891322083
·
Model: 81171
·
DIESSE DIAGNOSTICA SENESE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CHORUS Q FEVER PHASE II IgG
- Primary DI
- 08033891322083
- Version / Model
- 81171
- Catalog Number
- 81171
- Company Name
- DIESSE DIAGNOSTICA SENESE SPA
- Labeler DUNS
- 435036669
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-22
- Public Version
- 1
- Public Version Date
- 2024-01-30
- Public Version Status
- New
- Public Device Record Key
- 078dc65e-aac7-45e2-a3c8-69133e2f99d8
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GPS | Antigen, Cf, Q Fever | Microbiology | 866.3500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51350 | Coxiella burnetii immunoglobulin G (IgG) 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 immunoglobulin G (IgG) 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 | 08033891322083 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius