Amplivue GBS Assay
FDA 510(k) K133503 · Quidel Corporation
510(k) numberK133503
Submission
- Device name
- Amplivue GBS Assay
- Applicant
- Quidel Corporation
Athens, OH, US - Received
- November 14, 2013
- Decision date
- December 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
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Questions and answers
When was Amplivue GBS Assay cleared by the FDA?
Amplivue GBS Assay (K133503) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 36 days after the submission was received.
What is the product code of K133503?
The FDA product code is NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a Class I (low risk) device regulated under 21 CFR 866.3740.