FDA.reportPublic FDA data

IMMY

Primary DI
00816387020469
Brand
IMMY
Company
Immuno-Mycologics, Inc.
Model
ID1019
Device description
4-Series Cleargel ID Plates, Small Well
Published
2023-12-11
Public version status
New
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
JZPPlates, Ouchterlony Agar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZPPlates, Ouchterlony AgarImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816387020469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816387020469008163870204698163870204690816387020469

GMDN Terms#

Term, Definition table
TermDefinition
Agar medium preparation kit IVDA collection of devices intended to be used for the preparation of an agar medium for subsequent culture of a clinical specimen or other diagnostic testing (e.g., minimum susceptibility testing). It typically includes agarose, a specific culture media formulation and transfer devices (e.g., vial adaptor, syringe). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
14053604669customerservice@immy.com

Regulatory Flags#

DUNS number
099550915
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing 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
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
00816387020056IMMYA801102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816387020254IMMYImmuno-Mycologics, Inc.JZP2023-12-11
00816387020476IMMYImmuno-Mycologics, Inc.JZP2023-12-11
00816387020483IMMYImmuno-Mycologics, Inc.JZP2023-08-22
10634853000138Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000145Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000152Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000183Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000299Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000305Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000312Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26
10634853000343Fungal SerologyMICROBIOLOGICS INC.JZP2022-09-26