STANDARDIZE TGCL & TGCH
Device Facts
| Record ID | K781376 |
|---|---|
| Device Name | STANDARDIZE TGCL & TGCH |
| Applicant | American Monitor Corp. |
| Product Code | JTX · Microbiology |
| Decision Date | Sep 14, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
