| Primary Device ID | 07640158219300 |
| NIH Device Record Key | 2e3eb17c-fa5d-45a2-934c-cdabded7674f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Echinococcus multilocularis (Em2-Em18) IgG ELISA |
| Version Model Number | 9300 |
| Catalog Number | 9300 |
| Company DUNS | 487811143 |
| Company Name | Bordier affinity products S.A. |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch | |
| Phone | +41216333167 |
| cb@bordier.ch |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640158219300 [Primary] |
| GPF | Antigen, Agglutinating, Echinococcus 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 | 2022-08-17 |
| Device Publish Date | 2022-08-09 |
| 07640158219805 - Anisakidae IgG ELISA | 2022-10-13 The Anisakidae ELISA test is a qualitative enzyme immunoassay for the detection of Anisakidae antibodies in human serum samples. |
| 07640158219652 - Fasciola hepatica IgG ELISA | 2022-10-10 The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of Fasciola hepatica antibodies in human |
| 07640158219256 - Ascaris IgG ELISA | 2022-10-07 The Ascaris ELISA test is a qualitative enzyme immunoassay for the detection of Ascaris in human serum samples. |
| 07640158219201 - Toxocara canis IgG ELISA | 2022-10-06 The Toxocara canis ELISA test is a qualitative enzyme immunoassay for the detection of Toxocara canis antibodies in human serum |
| 07640158219409 - Acanthocheilonema viteae IgG ELISA | 2022-10-06 The Acanthocheilonema viteae ELISA test is a qualitative enzyme immunoassay for the detection of Acanthocheilonema viteae antibo |
| 07640158219751 - Trichinella spiralis IgG ELISA | 2022-10-06 The Trichinella spiralis ELISA test is a qualitative enzyme immunoassay for the detection of Trichinella spiralis in human serum |
| 07640158216101 - Aspergillus fumigatus IgG ELISA | 2022-09-29 The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus antibodies i |
| 07640158219706 - Taenia solium IgG ELISA | 2022-09-29 The Taenia solium ELISA test is a qualitative enzyme immunoassay for the detection of Taenia solium antibodies in human serum sa |