IMMY

GUDID 00816387020056

Aspergillus fumigatus ID Positive Control

IMMUNO-MYCOLOGICS, INC.

Aspergillus fumigatus total antibody IVD, control
Primary Device ID00816387020056
NIH Device Record Key0c9d3148-140d-478e-a6c1-b5fd6b9bcdf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMMY
Version Model NumberA80110
Company DUNS099550915
Company NameIMMUNO-MYCOLOGICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com
Phone14053604669
Emailcustomerservice@immy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816387020056 [Primary]

FDA Product Code

JWTAntigen, Cf, Aspergillus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [IMMY]

00816387021152CTA2003
00816387021145MycoDDR Resuspension Buffer C
00816387021121MycoDDR Neutralization Buffer B
00816387021107MycoDDR Neutralization Buffer B
00816387021084NALC Powder
008163870210533.0% NaOH Reagent A
008163870210462.5% NaOH Reagent A
00816387020995MycoDDR 3.0% NaOH Reagent Kit
00816387020988MycoDDR 2.5% NaOH Reagent Kit
00816387020964MycoDDR Prep Blue 3.0%
00816387020940MycoDDR Prep Blue - 2.5%
00816387020919Cryptococcal Antigen Lateral Flow Assay
00816387020872YA-Cryptococcus Antibody Detection System
00816387020865LA-Sporothrix Antibody System
00816387020858ID-Fungal Antibody System
00816387020841LA-Histoplasma Antibody System
00816387020834Latex-Cryptococcus Antigen Detection System
00816387020827Latex-Cryptococcus Antigen Detection System
00816387020810Latex Agglutination - Coccidioides Antibody System
00816387020803Coccidioides LA/ID Antibody System
00816387020797ID Candida Antibody System
00816387020773ALPHA Histoplasma Antigen EIA
00816387020759Cryptococcus Antigen EIA
00816387020728OMEGA Coccidioides Antibody EIA
00816387020704OMEGA Blastomyces Total Antibody EIA
00816387020605Histoplasma Yeast CF Antigen
00816387020599Histoplasma Mycelial CF Antigen
00816387020582Coccidioides CF Antigen
00816387020575Blastomyces CF Antigen
00816387020452Histoplasma Galactomannan Positive Control
00816387020445Histoplasma Galactomannan Negative Control
00816387020438Diluted HRP Anti Histoplasma mAb 26-10 IgG
00816387020421100 ng/mL Histoplasma Galactomannan
008163870204141000 EIA Unit Histoplasma Antigens
00816387020407Histoplasma ID Positive Control
00816387020391Histoplasma ID Antigen
00816387020384Histoplasma Yeast CF Positive Control
00816387020377Histoplasma Yeast CF Antigen Dilute
00816387020360Histoplasma Yeast CF Antigen Dilute
00816387020353Histoplasma Mycelial CF Positive Control
00816387020346Histoplasma Mycelial CF Antigen Dilute
00816387020339Histoplasma Mycelial CF Antigen Dilute
00816387020322Lateral Flow Specimen Diluent
00816387020292LF Titration Diluent
00816387020278Coccidioides IDTP Positive Control
00816387020261Cryptococcus Antigen External Positive Control
00816387020247Coccidioides IDTP Antigen
00816387020230Candida ID Positive Control
00816387020223Candida ID Antigen
00816387020216Coccidioides IDCF Positive Control

Trademark Results [IMMY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMMY
IMMY
98195832 not registered Live/Pending
Immuno-Mycologics, Inc.
2023-09-25
IMMY
IMMY
98157411 not registered Live/Pending
Immuno-Mycologics, Inc.
2023-08-30
IMMY
IMMY
98058421 not registered Live/Pending
Michael Kent
2023-06-26
IMMY
IMMY
90324627 not registered Live/Pending
Reardon, Maria
2020-11-17
IMMY
IMMY
85324252 4777394 Live/Registered
IMMY INC.
2011-05-18

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