Fobt-Chek
Positive Control for OC-Auto for Brazil
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
Record
| Listed by | Polymedco Cancer Diagnostic Products LLC |
|---|---|
| FDA product code | OOX |
| Device type | Automated Occult Blood Analyzer |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| 510(k) | K041408 |
| Record published | 2021-06-11 |
| Record revised | 2021-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OCQPBRZL | In distribution | |
| OCQNBRZL | In distribution | |
| OCQN | In distribution | |
| OCQP | In distribution | |
| OCIOQP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OC-Auto | Polymedco Cancer Diagnostic Products LLC | 727 |
| Color Stool Collection Kit | Color Diagnostics, LLC | 1 |
| Afias iFOB with AFIAS-50 | Boditech MED Inc. | 1 |
| ichroma™ iFOB | Boditech MED Inc. | 1 |
| ichroma Reader | Boditech MED Inc. | 1 |
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 |
|---|---|---|---|---|---|---|
| Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC. | UDI-DI | 2025-10-06 | Class III | Process control | A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17. | 403 units |
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.