| Primary Device ID | ENTIBRUG00500 |
| NIH Device Record Key | 8abd9d50-7457-4628-b64e-2472199e989a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovaLisa Brucella IgG |
| Version Model Number | BRUG0050 |
| Catalog Number | BRUG0050 |
| Company DUNS | 330328514 |
| Company Name | Gold Standard Diagnostics Frankfurt GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | ENTIBRUG00500 [Primary] |
| GSM | Antisera, Fluorescent, Brucella Spp. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-03 |
| Device Publish Date | 2024-08-26 |
| ENTIADVG00100 - NovaLisa Adenovirus IgG | 2024-09-10 The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Adenovirus in human serum |
| ENTIECHG01300 - NovaLisa Echinococcus IgG | 2024-09-10 The Echinococcus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Echinococcus in human s |
| ENTIENTG01400 - NovaLisa Entamoeba histolytica IgG | 2024-09-10 The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba hist |
| ENTIINFG02900 - NovaLisa Influenza Virus A IgG | 2024-09-10 The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A |
| ENTIINFG03000 - NovaLisa Influenza Virus B IgG | 2024-09-10 The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B |
| ENTILEPG06600 - NovaLisa Leptospira IgG | 2024-09-10 The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human |
| ENTIMEAG03300 - NovaLisa Measles Virus IgG | 2024-09-10 The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human |
| ENTIMUMG03400 - NovaLisa Mumps Virus IgG | 2024-09-10 The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human ser |