FDA.reportPublic FDA data

IMMY

Primary DI
00816387020841
Brand
IMMY
Company
Immuno-Mycologics, Inc.
Model
HL1001
Device description
LA-Histoplasma Antibody System
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
GMJAntigens, Histoplasma Capsulatum, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMJAntigens, Histoplasma Capsulatum, AllMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830837000LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.1983-05-05GMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816387020841PrimaryGS10
00816387020612Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816387020841008163870208418163870208410816387020841
00816387020612008163870206128163870206120816387020612

GMDN Terms#

Term, Definition table
TermDefinition
Histoplasma capsulatum total antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to the fungus Histoplasma capsulatum in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
14053604669customerservice@immy.com

Regulatory Flags#

DUNS number
099550915
Device count
80
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
00816387020339IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020346IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020360IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020377IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020391IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020599IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020605IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
00816387020858IMMYImmuno-Mycologics, Inc.GMJ2016-09-24
10634853000091Fungal SerologyMICROBIOLOGICS INC.GMJ2016-09-15
10634853000107Fungal SerologyMICROBIOLOGICS INC.GMJ2016-09-15
00840733101021Histoplasma Antigen for Fungal ImmunodiffusionMERIDIAN BIOSCIENCE, INC.GMJ2016-09-06