Assayed Quality Control Material For Clinical Microbiology Assays
The Assayed Quality Control Material For Clinical Microbiology Assays consists of serologic controls used with microbiology assays to verify assay performance and ensure accurate test results in clinical laboratory settings. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCH under regulation 866.3920 in the Microbiology specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QCH
- Device Class
- FDA class 2
- Regulation Number
- 866.3920
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Serologic controls for microbiology assays
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | Dec 30, 2025 | Substantially Equivalent | Techno-Path Manufacturing , Ltd. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.