Illumigene Group B Streptococcus Carrot Broth Claim

Q: What is the product code of K121044?

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.

FDA 510(k) K121044 · Meridian Bioscience, Inc.

Substantially Equivalent

510(k) numberK121044

Submission

Device name: Illumigene Group B Streptococcus Carrot Broth Claim
Applicant: Meridian Bioscience, Inc.
Cincinnati, OH, US
Received: April 6, 2012
Decision date: May 1, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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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K143312	Portrait GBS AssayNJR · Traditional	Great Basin Corporation	04/21/2015SE
K133503	Amplivue GBS AssayNJR · Traditional	Quidel Corporation	12/20/2013SE

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Questions and answers

When was Illumigene Group B Streptococcus Carrot Broth Claim cleared by the FDA?

Illumigene Group B Streptococcus Carrot Broth Claim (K121044) received a 510(k) decision of Substantially Equivalent on May 1, 2012, 25 days after the submission was received.

What is the product code of K121044?

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.