Isolator™ 1.5 Ml Microbial Tubes
The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Alere Scarborough, Inc., United States |
|---|---|
| FDA product code | LIO |
| Device type | Device, Specimen Collection |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2900 |
| 510(k) | K832246 |
| Record published | 2020-10-23 |
| Record revised | 2024-09-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50C5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 21 |
| Sigma Virocult | Medical Wire & Equipment Company (Bath), Ltd. | 16 |
| Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 14 |
| Puritan UniTranz-RT | Puritan Medical Products Company LLC | 13 |
| Sigma Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 11 |
| Starswab II Bacteriology Culture Collection and Transport System | Pretium Canada Packaging ULC | 10 |
| Vacuette | Greiner BIO-ONE Gmbh | 4 |
| Bacti-Swab | Remel, Inc. | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Puritan | Puritan Medical Products Company LLC | 4 |
| Covidien | Cardinal Health 200, LLC | 3 |
| Puritan Opti-Swab | Puritan Medical Products Company LLC | 3 |
Showing 12 of 35. All products under Device, Specimen Collection
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.