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

Biological Sterilization Indicator With Indirect Growth Detection

21 CFR 880.2806 / General Hospital
FDA source (opens on fda.gov)

QVB is the FDA product code for Biological Sterilization Indicator With Indirect Growth Detection, a class II device type, regulated under 21 CFR 880.2806. FDA's definition for this code 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 sterilization. Detection of surviving microorganisms is accomplished by a method other...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QVB
Device name
Biological Sterilization Indicator With Indirect Growth Detection
FDA definition
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 sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.
Regulation
21 CFR 880.2806
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QVB

By decision year
3 clearances under product code QVB with a decision year between 2024 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QVB by decision year
YearClearances
20241
20262

Applicants with the most clearances

Product code QVB
Applicants holding the most 510(k) clearances under product code QVB
ApplicantClearances
Steritec Products, Inc.1
Terragene LLC1
True Indicating LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code