Company ยท US
Immuno-Mycologics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2012. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
7recalls (1 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 7 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 6 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 3 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 3 |
| GMA | Antisera, Fluorescent, Sporothrix Schenekii | 1 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 1 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 1 |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 |
| JWT | Antigen, Cf, Aspergillus Spp. | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 |
| JXB | Kit, Identification, Yeast | 1 |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 1 |
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | 1 |
| LRF | Candida Spp., Direct Antigen, Id | 1 |
| MDU | Antigen, Elisa, Cryptococcus | 1 |
| MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | 1 |
| PPM | General Purpose Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2012 | K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA Immuno-Mycologics, Inc. | MDU |
| Mar 28, 2012 | K112422 | CRAG LATERAL FLOW ASSAY (LFA) Immuno-Mycologics, Inc. | GMD |
| Jul 20, 2011 | K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) Immuno-Mycologics, Inc. | GMD |
| Jul 19, 2011 | K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 Immuno-Mycologics, Inc. | MIZ |
| Aug 25, 1988 | K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT Immuno-Mycologics, Inc. | JTL |
| Feb 24, 1988 | K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 Immuno-Mycologics, Inc. | KFH |
| Oct 1, 1984 | K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 Immuno-Mycologics, Inc. | LRF |
| Jun 8, 1983 | K831918 | LA-STAPH IDENTIFICATION SYSTEM Immuno-Mycologics, Inc. | JWX |
| May 5, 1983 | K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 Immuno-Mycologics, Inc. | GMJ |
| Mar 20, 1981 | K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION Immuno-Mycologics, Inc. | GMD |
| Oct 31, 1980 | K802427 | LA-SPORO ANTIBODY SYSTEM Immuno-Mycologics, Inc. | GMA |
| Jun 2, 1980 | K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. Immuno-Mycologics, Inc. | JXB |
| Aug 16, 1979 | K791395 | ANTI-HISTOPLASMA SERUM #CF10025X Immuno-Mycologics, Inc. | GMK |
| Aug 16, 1979 | K791394 | HISTOPLASMA MYCELIAL #CF10020X Immuno-Mycologics, Inc. | GMJ |
| Aug 16, 1979 | K791393 | HISTOPLASMA YEAST ANTI #CF10021X Immuno-Mycologics, Inc. | GMJ |
| Aug 16, 1979 | K791392 | ANTI-HISTOPLASMA SERUM #CF10026X Immuno-Mycologics, Inc. | GMK |
| Aug 16, 1979 | K791390 | ANTI-BLASTOMYCES SERUM #CF10027X Immuno-Mycologics, Inc. | GMK |
| Aug 16, 1979 | K791389 | COCCIDIOIDES ANTIGEN #CF10023X Immuno-Mycologics, Inc. | GMI |
| Aug 16, 1979 | K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X Immuno-Mycologics, Inc. | GMH |
| Aug 16, 1979 | K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X Immuno-Mycologics, Inc. | JWT |
| Aug 16, 1979 | K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM Immuno-Mycologics, Inc. | KFG |
| Aug 16, 1979 | K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID Immuno-Mycologics, Inc. | GSN |
| Aug 16, 1979 | K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 Immuno-Mycologics, Inc. | GMJ |
| Aug 16, 1979 | K791383 | CANDIDA IMMUNODIFFUSION KIT #CA1001 Immuno-Mycologics, Inc. | GMI |
| Aug 16, 1979 | K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION Immuno-Mycologics, Inc. | GMD |
| Aug 16, 1979 | K791381 | COCCIDIODES (COCCI) Immuno-Mycologics, Inc. | GMG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Immuno-Mycologics, Inc Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60
For processing of clinical specimens for Mycobacterium spp. diagnosis Open, Classified |
PPM | None listed |
| Mar 18, 2025 | Immuno-Mycologics, Inc Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL
REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE Open, Classified |
GMI | None listed |
| Jan 3, 2022 | Immuno-Mycologics, Inc CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919 Terminated |
GMD | K112422 |
| Nov 4, 2019 | Immuno-Mycologics, Inc Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Te Terminated |
GMJ | K830837 |
| Mar 30, 2018 | Immuno-Mycologics, Inc Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003
Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detectio Terminated |
GMD | K112422 |
| Jan 27, 2017 | Immuno-Mycologics, Inc Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 Terminated |
GMD | K112422 |
| Jun 20, 2016 | Immuno-Mycologics, Inc Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150
The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to a Terminated |
GMJ | K791393 |