Early Discovery
Catalogue number HSED-3, listed by Immunostics, Inc., United States, under Reagent, Occult Blood. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
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 | Immunostics, Inc., United States |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K022755 |
| Record published | 2016-09-23 |
| Record revised | 2025-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not refrigerate or freeze.; Storage environment temperature 15 to 30 °C |
| Packaging | Case of 30 of 30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HSED-3 | 3 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171484 | 2017-06-14 |
| K163554 | 2017-01-17 |
| K102664 | 2011-01-28 |
| K060463 | 2006-06-06 |
| K992759 | 1999-12-06 |
| K902360 | 1990-07-27 |
| K854619 | 1986-03-03 |
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.