FDA 510(k)

IDI-MRSA

K-Number: K033415 · 2004-03-18

ApplicantInfectio Diagnostic (I.D.I.), Inc.

Decision Date2004-03-18

Product CodeNQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

IDI-MRSA is the device name listed in this FDA 510(k) record. The listed applicant is Infectio Diagnostic (I.D.I.), Inc.. It received FDA 510(k) clearance on 2004-03-18 under 510(k) number K033415. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDI-MRSA?

IDI-MRSA is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Infectio Diagnostic (I.D.I.), Inc.. The 510(k) number is K033415.

When did IDI-MRSA receive FDA 510(k) clearance?

IDI-MRSA received FDA 510(k) clearance on 2004-03-18, under 510(k) number K033415.

Who is the listed applicant for IDI-MRSA?

The FDA 510(k) record lists Infectio Diagnostic (I.D.I.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDI-MRSA?

The FDA product code for IDI-MRSA is NQX.

Other records listing Infectio Diagnostic (I.D.I.), Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042357IDI-MRSA ASSAY

Related Devices (Code: NQX)

K243625Xpert MRSA/SA SSTICepheid®K243070Xpert® SA Nasal CompleteCepheid®K191742ARIES MRSA AssayLuminex Corporation K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid K162444Xpert MRSA NxGCepheid K133605BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.