Henry Schein
Positive/Negative Controls for OC-Light and OC-Light S
5manufacturers in China registered for this device type
14catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| 510(k) | K041297 |
| Record published | 2020-02-24 |
| Record revised | 2022-04-08 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Special storage condition: Protect from heat, humidity and light. Do not store with volatile chemicals, e.g.iodine, chlorine (bleach), bromine or a |
| Packaging | Pack of 8, pack of 10, pack of 50, pack of 24, case of 12, case of 19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5701171 | In distribution | ||
| 1471246 | In distribution | ||
| 1127141 | In distribution | ||
| 9007458 | In distribution | ||
| 1471963 | In distribution | ||
| 5700607 | 20 | In distribution | |
| 5700609 | In distribution | ||
| 5701172 | In distribution | ||
| 1127142 | In distribution | ||
| 5700610 | In distribution | ||
| 9004413 | In distribution | ||
| 1477182 | In distribution | ||
| 9004416 | In distribution | ||
| 1127140 | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC. | 510(k) number | 2013-02-12 | Class II | Process control | The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative r | 355,350 test strips | 2016-02-10 |
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.