JSN · Culture Media, Propagating Transport
Microbiology · 21 CFR 866.2390 · Class 1
Overview
| Product Code | JSN |
|---|---|
| Device Name | Culture Media, Propagating Transport |
| Regulation | 21 CFR 866.2390 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000718 | CHROMOSTREAK | Novamed , Ltd. | Aug 24, 2000 | SESE |
| K962745 | ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) | Prepared Media Laboratory, Inc. | Oct 2, 1996 | SESE |
| K961756 | CYTOQUANT VIRAL TRANSPORT MEDIUM | Proteins Intl., Inc. | May 17, 1996 | SESE |
| K961755 | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM | Proteins Intl., Inc. | May 17, 1996 | SESE |
| K896296 | INPOUCH-TV POUCH | Biomed Diagnostics, Inc. | Jan 29, 1990 | SESE |
| K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K860967 | VIRTRAN VIRAL TRANSPORTER (MODIFIED) | Diagnon Corp. | Apr 4, 1986 | SESE |
| K841208 | PROPAGATING TRANSPORT | Smith River Biologicals | Apr 5, 1984 | SESE |
| K833968 | 10B | Remel Co. | Dec 30, 1983 | SESE |
| K834065 | A3B | Remel Co. | Dec 27, 1983 | SESE |
| K831186 | RAPID NFT | Dms Laboratories | May 9, 1983 | SESE |
| K792201 | STREP CULTURETTE | Marion Health & Safety, Inc. | Nov 30, 1979 | SESE |
| K781304 | TRANSPORT MEDIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 14, 1978 | SESE |
Top Applicants
- Proteins Intl., Inc. — 2 clearances
- Remel Co. — 2 clearances
- Acumedia Manufacturers, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biomed Diagnostics, Inc. — 1 clearance
