FDA UDI
In Commercial Distribution
🇺🇸 United States
NovaLisa Brucella IgG
DI: ENTIBRUG00500
·
Model: BRUG0050
·
Gold Standard Diagnostics Frankfurt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NovaLisa Brucella IgG
- Primary DI
- ENTIBRUG00500
- Version / Model
- BRUG0050
- Catalog Number
- BRUG0050
- Company Name
- Gold Standard Diagnostics Frankfurt GmbH
- Labeler DUNS
- 330328514
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 1
- Public Version Date
- 2024-09-03
- Public Version Status
- New
- Public Device Record Key
- 8abd9d50-7457-4628-b64e-2472199e989a
Device Description
The Brucella IgG ELISA is intended for the qualitative determination of IgG class antibodies against Brucella in human serum or plasma (citrate, heparin).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- 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 |
|---|---|---|---|---|
| GSM | Antisera, Fluorescent, Brucella Spp. | Microbiology | 866.3085 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50619 | Multiple Brucella species 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 one or multiple species of Brucella bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENTIBRUG00500 | HIBCC |
Customer Contacts
- Phone
- +1(888)977-4739
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius