IMMY

GUDID 00816387020384

Histoplasma Yeast CF Positive Control

IMMUNO-MYCOLOGICS, INC.

Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control Histoplasma capsulatum total antibody IVD, control

• Primary Device ID: 00816387020384
• NIH Device Record Key: e15b9bd0-8653-4fcb-b7d9-5e7d76e7ed11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMY
• Version Model Number: H40110
• 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	00816387020384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791392

FDA Product Code

• GMK: Antiserum, Positive Control, Histoplasma Capsulatum

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