EZ Detect Fecal Occult Blood Test
The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the…
The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool — an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use.
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 | Biomerica, United States |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K860028 |
| Record published | 2020-07-01 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1001 | In distribution | |
| 1001 | Withdrawn |
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
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.