OC-Light S
Personal Use Kit OC-Light S, Custom Kit for Comm Mem Hosp/Moorland Reserve Health Center (Froedert)
5manufacturers in China registered for this device type
59catalogue numbers in this listing
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 | Polymedco Cancer Diagnostic Products LLC |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| 510(k) | K143325 |
| Record published | 2018-09-23 |
| Record revised | 2022-06-10 (version 5) |
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 |
| Storage | Storage environment temperature 2 to 30 °C |
| Distribution end date | 2022-07-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FBPUS-ABRMP-ESK | In distribution | |
| FBPUS-MCWI | In distribution | |
| FBPUS-PCL | In distribution | |
| FBPUS-SCHS | In distribution | |
| FBPUS-TB | In distribution | |
| FBPUS-ALAM | In distribution | |
| FBPU-NBRMP-120S | In distribution | |
| FBPUS-AFPC | In distribution | |
| FBPUS-UFCH | In distribution | |
| FBPUS-ARMC | In distribution | |
| FBPUS-MBAP | In distribution | |
| FBPUS-AI | In distribution | |
| FBPU-ABRMP-120S | In distribution | |
| FBPUS-CHA ECCC | In distribution | |
| FBPUS-VA1 | In distribution | |
| FBPUS-LCHC | In distribution | |
| FBPU-BULKS | In distribution | |
| FBPUS-CMH FHMG | In distribution | |
| FBPUS-AAPH | In distribution | |
| FOB50S | In distribution | |
| FBPUS-BMHL | In distribution | |
| FBPUS-CMH MRHC | In distribution | |
| FBPUS-FMA | In distribution | |
| FBPU-CUSTOM-120S | In distribution | |
| FBPUS-OMC | In distribution | |
| FBPUS-GOSH | In distribution | |
| FBPUS-EHICH | In distribution | |
| FBPU-ABRMPS | In distribution | |
| FBPUS-UH | In distribution | |
| FBPUS-ADL | In distribution | |
| FBPUS-CHA CPCC | In distribution | |
| FBPUS-HHS | In distribution | |
| FBPUS-MWH | In distribution | |
| FBPUS-MONH | In distribution | |
| FBT-StarterS | In distribution | |
| FBPUS-VA1 BATH | In distribution | |
| FBPUS-LCPSC | In distribution | |
| FBPUS-AL | In distribution | |
| FOBBTLS | In distribution | |
| FBPU-120S | In distribution | |
| FBPUS-CHA MFMC | In distribution | |
| FBPUS-EC | In distribution | |
| FBPUS-GRPH | In distribution | |
| FBPUS-MCY | In distribution | |
| FBPUS-INOV | In distribution | |
| FBPU-CUSTOMS | In distribution | |
| FBPU-NBRMPS | In distribution | |
| FBPUS-UCSD | In distribution | |
| FBPUS-CHA FHMG | In distribution | |
| FBPUS-CA | In distribution | |
| FBPUS-CHWC | In distribution | |
| FBPUS-THSA | In distribution | |
| FOBSTRS | In distribution | |
| FBPUS-LHCH | In distribution | |
| FBPUS-VFC | In distribution | |
| FBPUS-WAFH | In distribution | |
| FBPU-ADRS | In distribution | |
| FBPUS | In distribution | |
| FBPUS-CHA SP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Medline | Medline Industries, Inc. | 5 |
Showing 12 of 135. All products under Reagent, Occult Blood
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.