FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020303
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
720-540
Device description
"""720-540 Mumps 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
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974552000DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.1998-01-28LJB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020303008172730203038172730203030817273020303

GMDN Terms#

Term, Definition table
TermDefinition
Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Measles virus in a clinical specimen, using a complement fixation test (CFT).

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
305-324-2300customersupport@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
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2026-05-29
00850054026156QMedix™Diagnostic Automation, Inc.LJB2025-06-05
ENTIMEAG03300NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
ENTIMEAG0330NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
08033891322434CHORUS MEASLES IgGDIESSE DIAGNOSTICA SENESE SPALJB2024-01-22
04048474059670Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2023-09-01
00840239059673Measles Virus IgG Avidity ELISADRG International IncLJB2023-08-26
00850049545396AccuDiag ™Diagnostic Automation, Inc.LJB2023-06-14
00847865010764Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJB2023-01-22
00404847459678Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2021-06-07
B3507205200Gold Standard Diagnostics Is-Measles IgG ELISA Test KitGold Standard Diagnostics CorporationLJB2020-05-20
05391516743631Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
05391516747127Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
03573026064532VIDAS® Measles IgGBIOMERIEUX SALJB2019-08-30
04048474038446Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00404847438444Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00840239038449Measles Virus IgG ELISADRG International IncLJB2019-03-20
04049016027973Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
04049016083276Avidity: Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00850487007104ReQuest QUEST INTERNATIONAL, INC.LJB2016-08-31
00850487007111ReQuestQUEST INTERNATIONAL, INC.LJB2016-08-31