Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Chagas Detect Plus Rapid Test

K-Number: K161947 · 2016-12-16

ApplicantInBios International, Inc.
Decision Date2016-12-16
Product CodeMIU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Chagas Detect Plus Rapid Test is a medical device manufactured by InBios International, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K161947. The device is classified under product code MIU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chagas Detect Plus Rapid Test?

Chagas Detect Plus Rapid Test is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by InBios International, Inc.. The 510(k) number is K161947.

When was Chagas Detect Plus Rapid Test approved by the FDA?

Chagas Detect Plus Rapid Test received FDA 510(k) clearance on 2016-12-16, under approval number K161947.

What company makes Chagas Detect Plus Rapid Test?

Chagas Detect Plus Rapid Test is manufactured by InBios International, Inc..

What is the FDA product code for Chagas Detect Plus Rapid Test?

The FDA product code for Chagas Detect Plus Rapid Test is MIU.

Related Clinical Trials

NCT05333679 Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) COMPLETED NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED

Other Devices by InBios International, Inc.

K181473DENV Detect NS1 ELISA DEN180069ZIKV Detect 2.0 IgM Capture ELISA DEN220044Active Anthrax DetectTM Plus Rapid Test K233358SCoV-2 Ag Detect Rapid Test K251595COVID-19 Detect Rapid Self -Test

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑