11-Dehydro Thromboxane B2 Kit, Urinary

OBW · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5700

Classification

FDA Product Code: OBW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.5700
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown