Calas Pronase
CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen Latex Agglutination System (CALAS).
1manufacturer
1catalogue number
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Genobio Pharmaceutical Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Meridian Bioscience, Inc., United States |
|---|---|
| FDA product code | GMD |
| Device type | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K894845 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 140050 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immy | Immuno-Mycologics, Inc. | 6 |
| Antisera, Latex Agglutination, Cryptococcus Neoformans | Remel, Inc. | 2 |
| Cryptococcal Antigen Latex Agglutination System (Calas) | Meridian Bioscience, Inc. | 1 |
| Antisera, Latex Agglutination, Cryptococcus Neoformans | Oxoid, Ltd. | 1 |
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.