FDA.reportPublic FDA data

IMMY

Primary DI
00816387020773
Brand
IMMY
Company
Immuno-Mycologics, Inc.
Model
HAG102
Device description
ALPHA Histoplasma Antigen EIA
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma CapsulatumMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101407000ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102Immuno-Mycologics, Inc.2011-07-19MIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816387020773PrimaryGS10
00816387020780Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816387020773008163870207738163870207730816387020773
00816387020780008163870207808163870207800816387020780

GMDN Terms#

Term, Definition table
TermDefinition
Histoplasma capsulatum antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Histoplasma capsulatum in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
14053604669customerservice@immy.com

Regulatory Flags#

DUNS number
099550915
Device count
96
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816387020223IMMYC501102016-09-24
00816387020230IMMYC601102016-09-24
00816387020797IMMYCA10012016-09-24
00816387020254IMMYCA10192023-12-11
00816387020285IMMYDE00102023-12-11
00816387020308IMMYEIABU32023-12-11
00816387020469IMMYID10192023-12-11
00816387020476IMMYID10292023-12-11
00816387020520IMMYN801102023-12-11
00816387020483IMMYID10392023-08-22
00816387020827IMMYCR10032016-09-24
00816387020834IMMYCR10042016-09-24
00816387020872IMMYYA10012016-09-24
00816387020810IMMYCL10012016-09-24
00816387021060IMMYNAOH302018-09-24
00816387020001IMMYA101502016-09-24
00816387020018IMMYA201102016-09-24
00816387020025IMMYA301102016-09-24
00816387020032IMMYA401102016-09-24
00816387020049IMMYA701102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816101022240DxSelect™ Amber Sample DiluentDIASORIN MOLECULAR LLCMIZ2016-09-22
20816101022230Histoplasma DxSelect™DIASORIN MOLECULAR LLCMIZ2016-09-22