Kit, Direct Antigen, Positive Control
The Direct Antigen Positive Control Kit is a quality control reagent used in clinical laboratories to serve as a known-positive specimen when validating or running direct antigen detection assays, ensuring that the test system accurately identifies the presence of the target antigen. Classified as a Class 1 device under 21 CFR 862.1660 within the Clinical Chemistry specialty, it is subject only to general controls and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJZ
- Device Class
- FDA class 1
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | Sep 01, 2009 | Substantially Equivalent | Binax, Inc. |
| K972182 | ABBOTT STREP A CONTROLS | Aug 13, 1997 | Substantially Equivalent | Abbott Diagnostics |
| K972129 | CHLAMYDIATROL AG | Aug 12, 1997 | Substantially Equivalent | Blackhawk Biosystems, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.