FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020259
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
720-440
Device description
"""720-440 anti-PR-3 (C-ANCA) 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
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983390000IS-ANTI-MPO IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-18MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020259008172730202598172730202590817273020259

GMDN Terms#

Term, Definition table
TermDefinition
Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)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 Echinococcus multilocularis in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Echinococcus multilocularis, a parasitic tapeworm associated with hydatid disease.

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
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
08059304340239dIFine ANCA ClassifierVISIA LAB SRLMOB2025-06-27
00845533001984Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001991Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
08426950627692QUANTA Flash PR3 ReagentsINOVA DIAGNOSTICS, INC.MOB2024-12-13
08426950627685QUANTA Flash® MPO ReagentsINOVA DIAGNOSTICS, INC.MOB2023-12-14
04049016159704EUROPLUS Granulocyte Mosaic 32EUROIMMUN Medizinische Labordiagnostika AGMOB2023-10-05
04048474027761Myeloperoxidase IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
04048474027778ANCA Screen IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
04048474027785Proteinase-3 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
00840239035967c-ANCA (PR3) ELISADRG International IncMOB2023-08-25
00840239035974pANCA (MPO) ELISADRG International IncMOB2023-08-25
00840239027764Myeloperoxidase IgG ELISADRG International IncMOB2023-08-23
00840239027771ANCA Screen IgG ELISADRG International IncMOB2023-08-23
00840239027788Proteinase-3 IgG ELISADRG International IncMOB2023-08-23
00813545029036MBO IgG Test SystemSCIMEDX CORPORATIONMOB2023-06-13
00813545029043PR3 IgG Test SystemSCIMEDX CORPORATIONMOB2023-06-13
B3507204300Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test KitGold Standard Diagnostics CorporationMOB2022-12-03
B3507204400Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test KitGold Standard Diagnostics CorporationMOB2022-12-03
07350008750098OMNERA 500AArcoma ABMOB2022-03-30
00894175000404AccuDiag ™ Diagnostic Automation, Inc.MOB2021-08-09
07333066014166EliA ANCA/GBM Positive Control 2500/5000Phadia ABMOB2020-12-09
04048474035971pANCA (MPO) ELISA)DRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-10
00404847435979pANCA (MPO) ELISA)DRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-10
04049016072102IFA: Granulocyte Mosaic 13EUROIMMUN Medizinische Labordiagnostika AGMOB2019-06-06
04048474035964c-ANCA (PR3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-05
00404847435962c-ANCA (PR3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-05
04049016108535IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108542IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04