510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN100020Unknown

Denv Detect Igm Capture Elisa

Inbios Intl., Inc., Seattle WA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN100020 is the FDA 510(k) clearance record for DENV DETECT IGM CAPTURE ELISA, a class II device, cleared for Inbios Intl., Inc. on under FDA product code OSU (Dengue Serological Reagents). FDA's definition for product code OSU reads: "Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory...". FDA records list 6 510(k) clearances for Inbios Intl., Inc., from to . As of , FDA records show no recalls naming DEN100020.

Clearance record

Decision date
Received
(170 days to decision)
Product code
OSU Dengue Serological Reagents
Regulation
21 CFR 866.3945
Device class
Class II
Review panel
Microbiology
Applicant
Inbios Intl., Inc. 562 1st Ave. S, Suite 600, Seattle WA
Third party review
No

Clearances, product code OSU

Trailing 12 months

FDA records hold no clearances under product code OSU in the trailing twelve months.

FDA records show no clearances under product code OSU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OSU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260