McKesson
Immunochemical Fecal Occult Blood Tests PATIENT KITS | TUBE COLLECTION
5manufacturers in China registered for this device type
21catalogue 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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Record published | 2017-09-29 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 127-100ER | 100 | In distribution | |
| 4487 | 25 | In distribution | |
| 178-CM50 | 50 | In distribution | |
| 127-50ER | 50 | In distribution | |
| 301 | In distribution | ||
| 4485 | 25 | In distribution | |
| 127-8DVER | 8 | In distribution | |
| 178-CT50 | 50 | In distribution | |
| 178-CT30 | 30 | In distribution | |
| 178-TB50 | 50 | In distribution | |
| 303 | 100 | In distribution | |
| 302 | 80 | In distribution | |
| 300 | 100 | In distribution | |
| 4486 | 10 | In distribution | |
| 178-CK30T | 30 | In distribution | |
| 178-CK50 | 50 | In distribution | |
| 551748 | In distribution | ||
| 298 | 80 | In distribution | |
| 178-CM25 | 25 | In distribution | |
| 4488 | 20 | In distribution | |
| 178-CK30 | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OC-Light S | Polymedco Cancer Diagnostic Products LLC | 59 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | boxes: a. 20 b. 21 c. 4 |
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.