# K993812: CVM Transport, Model R96,Viral Transport, Model R99, CVM Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Dec 21, 1999 after 41 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenzae A, Influenzae B, Respiratory Synctial Virus (RSV), Echovirus, Adenovirous, Chlamydia trachomatis, C. pneumoniae, Mycoplasma hominis, M. pneumoniae and Ureaplasma urealyticum. CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Respiratory Synctial Virus (RSV), Echovirus, and Adenovirous.

Source page: https://510kreport.com/device/K993812
Methodology: https://510kreport.com/methodology