Immuno-Mycologics, Inc.
Immuno-Mycologics, Inc. holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2012, with 7 FDA device recalls on record.
Top product codes for Immuno-Mycologics, Inc.
FDA recalls by Immuno-Mycologics, Inc.
- Z-1984-2026 — Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
- Z-1389-2025 — 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
- Z-0545-2022 — 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
- Z-2301-2020 — 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 Test, Histoplasma ID Antigen
- Z-2409-2018 — 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 detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
- Z-1109-2017 — Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- Z-2040-2016 — 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 aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Immuno-Mycologics, Inc.
- K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIA
- K112422 — CRAG LATERAL FLOW ASSAY (LFA)
- K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA)
- K101407 — ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
- K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
- K880029 — EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
- K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI1001
- K831918 — LA-STAPH IDENTIFICATION SYSTEM
- K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001
- K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
- K802427 — LA-SPORO ANTIBODY SYSTEM
- K800908 — CAPIK-CANDIDA ALBICANS IDENT. KIT.
- K791381 — COCCIDIODES (COCCI)
- K791382 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
- K791383 — CANDIDA IMMUNODIFFUSION KIT #CA1001
- K791384 — FUNGAL IMMUNODIFFUSION KIT #ID1001
- K791385 — NEGATIVE CONTROL SERUM FOR CF RO ID
- K791386 — ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
- K791387 — ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
- K791388 — ANTI-COCCIDIOIDES SERUM #CF10028X
- K791389 — COCCIDIOIDES ANTIGEN #CF10023X
- K791390 — ANTI-BLASTOMYCES SERUM #CF10027X
- K791392 — ANTI-HISTOPLASMA SERUM #CF10026X
- K791393 — HISTOPLASMA YEAST ANTI #CF10021X
- K791394 — HISTOPLASMA MYCELIAL #CF10020X
- K791395 — ANTI-HISTOPLASMA SERUM #CF10025X
Data sourced from openFDA. This site is unofficial and independent of the FDA.