DeviceClearance

Product code GTY— Microbiology

SAS STREPALERT

Classification name
Antigens, All Groups, Streptococcus Spp.
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Total cleared
44
First cleared
Most recent

Market context for product code GTY

FDA has cleared 44 devices under product code GTY between 1981 and 2026, filed by 29 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code GTY

Adverse events under product code GTY

product code GTY
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GTY

Data sourced from openFDA. This site is unofficial and independent of the FDA.