InSure FIT
InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each)
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Enterix Inc., United States |
|---|---|
| FDA product code | OSL |
| Device type | Control, Fecal Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K101831 |
| Record published | 2016-09-20 |
| Record revised | 2020-04-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Protect from heat and direct sun light; Storage environment temperature 36 to 46 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osom iFOB Control Kit | Sekisui Diagnostics, LLC | 1 |
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.