IMMY
GUDID 00816387020827
Latex-Cryptococcus Antigen Detection System
IMMUNO-MYCOLOGICS, INC.
Cryptococcus neoformans antigen IVD, kit, agglutination, rapid| Primary Device ID | 00816387020827 |
| NIH Device Record Key | cfcfe064-5821-4f5c-b4a2-90f85ccffd6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMY |
| Version Model Number | CR1003 |
| Company DUNS | 099550915 |
| Company Name | IMMUNO-MYCOLOGICS, INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816387020827 [Primary] |
| GS1 | 00816387020889 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K791382
FDA Product Code
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [IMMY]
| 00816387021152 | CTA2003 |
| 00816387021145 | MycoDDR Resuspension Buffer C |
| 00816387021121 | MycoDDR Neutralization Buffer B |
| 00816387021107 | MycoDDR Neutralization Buffer B |
| 00816387021084 | NALC Powder |
| 00816387021053 | 3.0% NaOH Reagent A |
| 00816387021046 | 2.5% NaOH Reagent A |
| 00816387020995 | MycoDDR 3.0% NaOH Reagent Kit |
| 00816387020988 | MycoDDR 2.5% NaOH Reagent Kit |
| 00816387020964 | MycoDDR Prep Blue 3.0% |
| 00816387020940 | MycoDDR Prep Blue - 2.5% |
| 00816387020919 | Cryptococcal Antigen Lateral Flow Assay |
| 00816387020872 | YA-Cryptococcus Antibody Detection System |
| 00816387020865 | LA-Sporothrix Antibody System |
| 00816387020858 | ID-Fungal Antibody System |
| 00816387020841 | LA-Histoplasma Antibody System |
| 00816387020834 | Latex-Cryptococcus Antigen Detection System |
| 00816387020827 | Latex-Cryptococcus Antigen Detection System |
| 00816387020810 | Latex Agglutination - Coccidioides Antibody System |
| 00816387020803 | Coccidioides LA/ID Antibody System |
| 00816387020797 | ID Candida Antibody System |
| 00816387020773 | ALPHA Histoplasma Antigen EIA |
| 00816387020759 | Cryptococcus Antigen EIA |
| 00816387020728 | OMEGA Coccidioides Antibody EIA |
| 00816387020704 | OMEGA Blastomyces Total Antibody EIA |
| 00816387020605 | Histoplasma Yeast CF Antigen |
| 00816387020599 | Histoplasma Mycelial CF Antigen |
| 00816387020582 | Coccidioides CF Antigen |
| 00816387020575 | Blastomyces CF Antigen |
| 00816387020452 | Histoplasma Galactomannan Positive Control |
| 00816387020445 | Histoplasma Galactomannan Negative Control |
| 00816387020438 | Diluted HRP Anti Histoplasma mAb 26-10 IgG |
| 00816387020421 | 100 ng/mL Histoplasma Galactomannan |
| 00816387020414 | 1000 EIA Unit Histoplasma Antigens |
| 00816387020407 | Histoplasma ID Positive Control |
| 00816387020391 | Histoplasma ID Antigen |
| 00816387020384 | Histoplasma Yeast CF Positive Control |
| 00816387020377 | Histoplasma Yeast CF Antigen Dilute |
| 00816387020360 | Histoplasma Yeast CF Antigen Dilute |
| 00816387020353 | Histoplasma Mycelial CF Positive Control |
| 00816387020346 | Histoplasma Mycelial CF Antigen Dilute |
| 00816387020339 | Histoplasma Mycelial CF Antigen Dilute |
| 00816387020322 | Lateral Flow Specimen Diluent |
| 00816387020292 | LF Titration Diluent |
| 00816387020278 | Coccidioides IDTP Positive Control |
| 00816387020261 | Cryptococcus Antigen External Positive Control |
| 00816387020247 | Coccidioides IDTP Antigen |
| 00816387020230 | Candida ID Positive Control |
| 00816387020223 | Candida ID Antigen |
| 00816387020216 | Coccidioides IDCF Positive Control |
Trademark Results [IMMY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMY 98195832 not registered Live/Pending |
Immuno-Mycologics, Inc. 2023-09-25 |
 IMMY 98157411 not registered Live/Pending |
Immuno-Mycologics, Inc. 2023-08-30 |
 IMMY 98058421 not registered Live/Pending |
Michael Kent 2023-06-26 |
 IMMY 90324627 not registered Live/Pending |
Reardon, Maria 2020-11-17 |
 IMMY 85324252 4777394 Live/Registered |
IMMY INC. 2011-05-18 |
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