FDA.reportPublic FDA data

IMMY

Primary DI
00816387021145
Brand
IMMY
Company
Immuno-Mycologics, Inc.
Model
TBRB30
Device description
MycoDDR Resuspension Buffer C
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
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816387021138PackageGS160In Commercial Distribution
00816387021145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816387021138008163870211388163870211380816387021138
00816387021145008163870211458163870211450816387021145

GMDN Terms#

Term, Definition table
TermDefinition
Mycobacteria specimen digestion/decontamination 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 liquefication, digestion, and/or decontamination of clinical specimens suspected of containing Mycobacteria microorganisms in preparation for further processing.

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
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
00846405012282Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012299Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012367Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012374Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012381Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012398Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012404Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012480Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014095Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014132Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014217Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014224Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405016716Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017065Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017072Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017089Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017362Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405019298Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023233Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023257Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023264Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023318Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023325Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023974Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405024421Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07