IMMY

GUDID 00816387020605

Histoplasma Yeast CF Antigen

IMMUNO-MYCOLOGICS, INC.

Histoplasma capsulatum total antibody IVD, kit, complement fixation test (CFT)

• Primary Device ID: 00816387020605
• NIH Device Record Key: d8f6f7ee-dfcb-4399-8875-f92b6ae76d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMY
• Version Model Number: QDXH90
• Company DUNS: 099550915
• Company Name: IMMUNO-MYCOLOGICS, INC.
• Device Count: 1
• 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

• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com
• Phone: 14053604669
• Email: customerservice@immy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816387020605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791384

FDA Product Code

• GMJ: Antigens, Histoplasma Capsulatum, All

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