Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
The Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium (product code NDZ) is an in vitro diagnostic test that uses nucleic acid amplification technology to identify Mycobacterium species from clinical specimens, supporting diagnosis of tuberculosis and related infections. It is classified as an FDA Class 1 device within the Microbiology specialty, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NDZ
- Device Class
- FDA class 1
- Regulation Number
- 866.3370
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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 |
|---|---|---|---|---|
| K000884 | BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY | Jan 19, 2001 | Substantially Equivalent | Becton Dickinson Biosciences |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.