ISH Protease 1
Catalogue number 05273315001, listed by Ventana Medical Systems, Inc., United States, under Trypsin. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1recall
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guang XI Fulaiming Biopharmaceutics Co., Ltd. | Nanning | Guangxi | Manufacturer | 12 |
Record
| Listed by | Ventana Medical Systems, Inc., United States |
|---|---|
| FDA product code | IBG |
| Device type | Trypsin |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-29 |
| Record revised | 2025-07-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05273315001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LensHooke Liquefaction Enzyme | Bonraybio Co., Ltd. | 2 |
| Protease 1 | Ventana Medical Systems, Inc. | 1 |
| ISH Protease 2 | Ventana Medical Systems, Inc. | 1 |
| ISH Protease 3 | Ventana Medical Systems, Inc. | 1 |
| Protease 3 | Ventana Medical Systems, Inc. | 1 |
| Protease 2 | Ventana Medical Systems, Inc. | 1 |
| QwikCheck Liquefaction | M.E.S. Medical Electronic Systems Ltd. | 1 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-08-02 | Class I | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | 2231 units | 2021-11-22 |
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.