Cryptococcal Antigen Latex Agglutination System (Calas)
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus…
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).
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 | 2022-11-28 (version 4) |
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 |
|---|---|---|
| 140100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immy | Immuno-Mycologics, Inc. | 6 |
| Antisera, Latex Agglutination, Cryptococcus Neoformans | Remel, Inc. | 2 |
| Calas Pronase | 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.