510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220042Unknown

Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

Terragene LLC, Alvear, AR / Direct, Unknown
FDA source (opens on fda.gov)

DEN220042 is the FDA 510(k) clearance record for Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH), a class II device, cleared for Terragene S.A. on under FDA product code QVB (Biological Sterilization Indicator With Indirect Growth Detection). FDA's definition for product code QVB reads: "A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of...". FDA records list 9 510(k) clearances for Terragene S.A., from to . As of , FDA records show no recalls naming DEN220042.

Clearance record

Decision date
Received
(742 days to decision)
Product code
QVB Biological Sterilization Indicator With Indirect Growth Detection
Regulation
21 CFR 880.2806
Device class
Class II
Review panel
General Hospital
Applicant
Terragene S.A. Ruta Nacional # 9, Km 280, Parque Industrial Micropi, Alvear, AR
Third party review
No

Clearances, product code QVB

Trailing 12 months
2 clearances under product code QVB in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260