Immy
Latex-Cryptococcus Antigen Detection System
1manufacturer
6catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Immuno-Mycologics, Inc., United States |
|---|---|
| FDA product code | GMD |
| Device type | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| 510(k) | K791382 |
| Record published | 2016-09-24 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CR2003 | 50 | In distribution | |
| CR1003 | 50 | In distribution | |
| YA1001 | In distribution | ||
| GLF065 | In distribution | ||
| CR1004 | 120 | In distribution | |
| EI0010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Antisera, Latex Agglutination, Cryptococcus Neoformans | Remel, Inc. | 2 |
| Cryptococcal Antigen Latex Agglutination System (Calas) | Meridian Bioscience, Inc. | 1 |
| Calas Pronase | Meridian Bioscience, Inc. | 1 |
| Antisera, Latex Agglutination, Cryptococcus Neoformans | Oxoid, Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112422 | 2012-03-28 |
| K102286 | 2011-07-20 |
| K810510 | 1981-03-20 |
| K791382 | 1979-08-16 |
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.