FDA.reportPublic FDA data

IMMY

Primary DI
00816387020384
Brand
IMMY
Company
Immuno-Mycologics, Inc.
Model
H40110
Device description
Histoplasma Yeast CF Positive Control
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
GMKAntiserum, Positive Control, Histoplasma Capsulatum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMKAntiserum, Positive Control, Histoplasma CapsulatumMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791392000ANTI-HISTOPLASMA SERUM #CF10026XImmuno-Mycologics, Inc.1979-08-16GMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816387020384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816387020384008163870203848163870203840816387020384

GMDN Terms#

Term, Definition table
TermDefinition
Histoplasma capsulatum total antibody IVD, controlA material which is used to verify the performance of an assay intended to be 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
1
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
00816387020353IMMYImmuno-Mycologics, Inc.GMK2016-09-24
00816387020407IMMYImmuno-Mycologics, Inc.GMK2016-09-24
00840733101052Anti-Histoplasma Control Serum (Goat) for ImmunodiffusionMERIDIAN BIOSCIENCE, INC.GMK2016-09-22
10634853000114Fungal SerologyMICROBIOLOGICS INC.GMK2016-09-15
10634853000121Fungal SerologyMICROBIOLOGICS INC.GMK2016-09-15