Product code NDZ— Microbiology
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
- Classification name
- Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
- Device class
- Class 1
- Regulation
- 21 CFR 866.3370
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code NDZ
FDA has cleared device under product code NDZ, all in 2001, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code NDZ
Recent clearances under product code NDZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.