Amplivue Gas Assay
FDA 510(k) K141173 · Quidel Corporation
510(k) numberK141173
Submission
- Device name
- Amplivue Gas Assay
- Applicant
- Quidel Corporation
Athens, OH, US - Received
- May 6, 2014
- Decision date
- July 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGX – Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2680
- Specialty
- Microbiology
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
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Questions and answers
When was Amplivue Gas Assay cleared by the FDA?
Amplivue Gas Assay (K141173) received a 510(k) decision of Substantially Equivalent on July 24, 2014, 79 days after the submission was received.
What is the product code of K141173?
The FDA product code is PGX – Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 866.2680.