Idi-Mrsa Assay
FDA 510(k) K042357 · Infectio Diagnostic (I.D.I.), Inc.
510(k) numberK042357
Submission
- Device name
- Idi-Mrsa Assay
- Applicant
- Infectio Diagnostic (I.D.I.), Inc.
Hydes, MD, US - Received
- August 31, 2004
- Decision date
- October 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
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More from Cepheid
| 510(k) | Device | Decision |
|---|---|---|
| K033415 | Idi-MrsaNQX · Traditional | 03/18/2004SE |
Questions and answers
When was Idi-Mrsa Assay cleared by the FDA?
Idi-Mrsa Assay (K042357) received a 510(k) decision of Substantially Equivalent on October 22, 2004, 52 days after the submission was received.
What is the product code of K042357?
The FDA product code is NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.