ForSure iFOB Test Set
ForSure iFOB test set Contains: 1 test device 1 test reagent buffer 1 sample collection set (may or may not be included)
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Syntron Bioresearch, Inc., United States |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K063693 |
| Record published | 2016-09-24 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Kit box of 50, kit box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10210 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OC-Light S | Polymedco Cancer Diagnostic Products LLC | 59 |
| McKesson | Mckesson Medical-Surgical Inc. | 21 |
| Hemosure | Hemosure Inc. | 21 |
| Hemoccult | Beckman Coulter, Inc. | 17 |
| Henry Schein | Henry Schein, Inc. | 14 |
| PremierPro | Prestige Ameritech | 11 |
| hema-screen Specific | Immunostics, Inc. | 9 |
| InSure® ONE™ | Enterix Inc. | 8 |
| InSure FIT | Enterix Inc. | 7 |
| hema-screen | Immunostics, Inc. | 7 |
| ADS Medical | W.h.p.m., Inc. | 7 |
| QuickVue | Quidel Corp. | 6 |
Showing 12 of 135. All products under Reagent, Occult Blood
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alere North Americal | 510(k) number | 2011-03-21 | Not classified | Other | Potential for false negatives test results and negative/faint positive controls | 3900 kits | 2013-03-07 |
| Alere North Americal | 510(k) number | 2011-03-21 | Not classified | Other | Potential for false negatives test results and negative/faint positive controls | 1594 kits | 2013-03-07 |
| Alere North Americal | 510(k) number | 2011-03-21 | Not classified | Other | Potential for false negatives test results and negative/faint positive controls | 1800 units | 2013-03-07 |
| Alere North Americal | 510(k) number | 2011-03-21 | Not classified | Other | Potential for false negatives test results and negative/faint positive controls | 500 units | 2013-03-07 |
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.