Immuno-Mycologics, Inc
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 26
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1984-2026 | Class II | Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of | March 26, 2026 |
| Z-1389-2025 | Class II | Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Con | February 10, 2025 |
| Z-0545-2022 | Class II | CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal | January 3, 2022 |
| Z-2301-2020 | Class II | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included F | November 4, 2019 |
| Z-2409-2018 | Class II | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Latera | March 30, 2018 |
| Z-1109-2017 | Class II | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 | December 27, 2016 |
| Z-2040-2016 | Class II | Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive c | May 9, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | December 17, 2012 |
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | March 28, 2012 |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | July 20, 2011 |
| K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | July 19, 2011 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | August 25, 1988 |
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | February 24, 1988 |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | October 1, 1984 |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | June 8, 1983 |
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | May 5, 1983 |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | March 20, 1981 |
| K802427 | LA-SPORO ANTIBODY SYSTEM | October 31, 1980 |
| K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. | June 2, 1980 |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | August 16, 1979 |
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X | August 16, 1979 |
| K791395 | ANTI-HISTOPLASMA SERUM #CF10025X | August 16, 1979 |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | August 16, 1979 |
| K791394 | HISTOPLASMA MYCELIAL #CF10020X | August 16, 1979 |
| K791389 | COCCIDIOIDES ANTIGEN #CF10023X | August 16, 1979 |
| K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | August 16, 1979 |
| K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 | August 16, 1979 |