Company ยท US
InBios International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | 1 |
| PIT | Leishmania Spp. Antigen Detection Assay | 1 |
| QCU | Dengue Virus Antigen Assay | 1 |
| QFO | Zika Virus Serological Reagents | 1 |
| QUU | Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples | 1 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 2025 | K251595 | COVID-19 Detect Rapid Self -Test InBios International, Inc. | QYT |
| Aug 23, 2024 | K233358 | SCoV-2 Ag Detect Rapid Test InBios International, Inc. | QVF |
| Feb 3, 2023 | DEN220044 | Active Anthrax DetectTM Plus Rapid Test InBios International, Inc. | QUU |
| May 23, 2019 | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. | QFO |
| Aug 27, 2018 | K181473 | DENV Detect NS1 ELISA InBios International, Inc. | QCU |
| Dec 16, 2016 | K161947 | Chagas Detect Plus Rapid Test InBios International, Inc. | MIU |
| Nov 14, 2014 | K141341 | CL DETECT RAPID TEST InBios International, Inc. | PIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||