Kit, Identification, Mycobacteria
Kit, Identification, Mycobacteria is a diagnostic microbiology kit used to identify mycobacterial species from clinical isolates, including organisms responsible for tuberculosis (Mycobacterium tuberculosis) and nontuberculous mycobacterial infections. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JSY, regulated under 21 CFR 866.2660, and falls within the Microbiology medical specialty.
Basic Information
- Product Code
- JSY
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K943051 | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT | Mar 13, 1995 | Substantially Equivalent | DYNAGEN, INC. |
| K943050 | MYCOAKT M KANSASII CULTURE ID KIT | Mar 13, 1995 | Substantially Equivalent | DYNAGEN, INC. |
| K943049 | MYCOAKT M. AVIUM CULTURE ID KIT | Mar 13, 1995 | Substantially Equivalent | DYNAGEN, INC. |
| K880990 | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | Mar 24, 1988 | Substantially Equivalent | ALPHA-TEC SYSTEMS, INC. |
| K830211 | API TB-IDENT* | Mar 24, 1983 | Substantially Equivalent | ANALYTICAL PRODUCTS, 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.