FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020310
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
720-600
Device description
"""720-600 EBV-VCA IgG Test Kit"""
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJYEnzyme Linked Immunoabsorbent Assay, Mumps VirusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020310008172730203108172730203100817273020310

GMDN Terms#

Term, Definition table
TermDefinition
Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblotA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Cryptosporidium parvum in a clinical specimen, using an immunoblot method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
305-324-2300customerservice@erbadiagnostics.com

Regulatory Flags#

DUNS number
151765328
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817273020167Diamedix720-3302016-09-20
00817273020181Diamedix720-3502016-09-20
00817273020044Diamedix300-371A2016-09-20
00817273020013Diamedix251-0352016-09-20
00817273020372Diamedix720-7002016-09-20
00817273020006Diamedix250-0302016-09-20
00817273020020Diamedix300-312A2016-09-20
00817273020037Diamedix300-331A2016-09-20
00817273020051Diamedix720-1302016-09-20
00817273020068Diamedix720-2302016-09-20
00817273020075Diamedix720-2402016-09-20
00817273020082Diamedix720-2502016-09-20
00817273020099Diamedix72-2602016-09-20
00817273020105Diamedix720-2702016-09-20
00817273020112Diamedix720-2802016-09-20
00817273020129Diamedix720-2902016-09-20
00817273020136Diamedix720-3002016-09-20
00817273020143Diamedix720-3102016-09-20
00817273020150Diamedix720-3202016-09-20
00817273020174Diamedix720-3402016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIMUMG03400NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
ENTIMUMG0340NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
00840239038470Mumps IgM ELISADRG International IncLJY2024-08-20
04048474038477Mumps IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2024-08-20
08033891322458CHORUS MUMPS IgGDIESSE DIAGNOSTICA SENESE SPALJY2024-01-22
00847865010771Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJY2023-01-04
00894175000060AccuDiag ™ Diagnostic Automation, Inc.LJY2021-08-10
B3507205400Gold Standard Diagnostics Is-Mumps IgG ELISA Test KitGold Standard Diagnostics CorporationLJY2020-07-27
05391516743600Trinity BiotechCLARK LABORATORIES, INC.LJY2019-10-25
03573026064525VIDAS® Mumps IgGBIOMERIEUX SALJY2019-09-16
04048474038460Mumps Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2019-06-05
00404847438468Mumps Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2019-06-05
00840239038463Mumps Virus IgG ELISADRG International IncLJY2019-03-20
05391516747110Trinity BiotechCLARK LABORATORIES, INC.LJY2017-05-07
04049016028017Anti-Mumps Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016028024Anti-Mumps Virus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016083283Anti-Mumps Virus AT ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016103646Anti-Mumps Virus ELISA (G5) (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
05391516743617Trinity BiotechCLARK LABORATORIES, INC.LJY2016-09-23
05391516743624Trinity BiotechCLARK LABORATORIES, INC.LJY2016-09-23
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00850487007081ReQuest QUEST INTERNATIONAL, INC.LJY2016-08-31