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Sign in to claim this brandInBios International, Inc.
United States·US-MF-000020625
Last updated September 17, 2026
About
Healthy As A Horse? As riding season gets underway, horses are more vulnerable to West Nile Virus (WNV). Veterinary diagnostic laboratories recommend IgM ELISA testing for WNV in horses, as it is capable of identifying recent exposure. Since 2013, InBios has been a
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 307, Westlake Ave N, Seattle, United States
- Website
- InBios.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Annabel Tsai
- EUDAMED SRN
- US-MF-000020625
- FDA FEI Number
- 3002606748
- DUNS Number
- —
Catalogue (34)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SCoV-2 Detect™ IgG Rapid Test | COVG-RE | FDA UDI | N | Active |
| SCoV-2 Detect™ Neutralizing Ab ELISA | COVN-E | FDA UDI | N | Active |
| SCoV-2 Ag Detect™ Rapid Test | COVAF-20 | FDA UDI | N/A | Active |
| SCoV-2 Ag Detect™ Rapid Test | COVAF-50 | FDA UDI | N/A | Active |
| SCoV-2 Detect™ IgG ELISA | COVE-G | FDA UDI | N | Active |
| SCoV-2 Detect™ IgM ELISA | COVE-M | FDA UDI | N | Active |
| Active Anthrax Detect Plus Rapid Test | AAP-1 | FDA UDI | Class II | Active |
| SCoV-2 Ag Detect™ Rapid Self-Test | CAGS-2 | FDA UDI | N | Active |
| SCoV-2 Ag Detect™ Rapid Test | COVAG-RC | FDA UDI | N | Active |
| Strongy DetectTM IgG ELISA | STNG-1 | FDA UDI | N/A | Active |
| ZIKV Detect™ 2.0 IgM Capture ELISA | IVD | FDA UDI | N/A | Active |
| Smart DetectTM SARS-CoV-2 rRT-PCR Kit | COV2-E | FDA UDI | N | Active |
| DENV Detect™ IgG ELISA | DDGS-1 | EUDAMED | IVD General | Active |
| JE Detect™ IgM Antibody Capture ELISA (MAC-ELISA) | JEMS-1 | EUDAMED | IVD General | Active |
| SCoV-2 Ag Detect Rapid Test | K233358 | FDA 510(k) | Class II | Active |
| COVID-19 Detect Rapid Self -Test | K251595 | FDA 510(k) | Class II | Active |
| DENV Detect NS1 ELISA | K181473 | FDA 510(k) | Class II | Active |
| ZIKV Detect 2.0 IgM Capture ELISA | DEN180069 | FDA 510(k) | Class II | Active |
| Chagas Detect Plus Rapid Test | K161947 | FDA 510(k) | Class I | Active |
| Cl Detect Rapid Test | K141341 | FDA 510(k) | Class I | Active |
| Active Anthrax DetectTM Plus Rapid Test | DEN220044 | FDA 510(k) | Class II | Active |
| Chagas Detect™ Plus Rapid Test | CP050 | EUDAMEDFDA UDI | IVD General | Active |
| West Nile Detect™ IgM Capture ELISA | WNMS-1 | EUDAMEDFDA UDI | IVD General | Active |
| DENV Detect™ IgM Capture ELISA | DDMS-1 | EUDAMEDFDA UDI | IVD General | Active |
| CL Detect™ Rapid Test | CL025 | EUDAMEDFDA UDI | IVD General | Active |
| DENV Detect™ NS1 ELISA | DNS1-1 | EUDAMEDFDA UDI | IVD General | Active |
| Scrub Typhus Detect™ IgG ELISA | STGS-1 | EUDAMED | IVD General | Active |
| Scrub Typhus Detect™ IgM ELISA | STMS-1 | EUDAMED | IVD General | Active |
| Dengue NS1 Detect™ Rapid Test | DNS1-RD | EUDAMED | IVD General | Active |
| ZIKV Detect™ 2.0 IgM Capture ELISA | ZKM2-1 | EUDAMED | IVD General | Active |
| Kalazar Detect™ Rapid Test | INS025 | EUDAMEDFDA UDI | IVD General | Active |
| CHIKjj Detect™ IgG ELISA | CHKG-C | EUDAMED | IVD General | Active |
| CHIKjj Detect™ IgM ELISA | CHKM-C | EUDAMED | IVD General | Active |
| Kalazar Detect™ Rapid Test | INS015 | EUDAMED | IVD General | Active |
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