FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
Device Facts
| Record ID | K962306 |
|---|---|
| Device Name | FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES |
| Applicant | Diagnostic Hybrids, Inc. |
| Product Code | KIR · Hematology |
| Decision Date | Aug 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2280 |
| Device Class | Class 1 |
Indications for Use
Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus HSV Influenza Measles Mumps Parainfluenza Poliovirus RSV Rotavirus
Device Story
FreshCells™ A549 cell line; provided as nearly confluent monolayers; used by laboratory personnel for virus isolation and identification from clinical samples; cells susceptible to specific viruses (Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, Rotavirus); enables viral confirmation via cell culture techniques; supports clinical diagnostic workflows.
Clinical Evidence
Bench testing only. Characterization tests performed: appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility.
Technological Characteristics
A549 cell line; provided as nearly confluent monolayers; sourced from ATCC or approved supplier; requires pre-incubation prior to use.
Indications for Use
Indicated for use in the isolation and confirmation of Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, and Rotavirus from clinical samples.
Regulatory Classification
Identification
Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
Predicate Devices
- BioWhittaker cell cultures
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