FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020020
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
300-312A
Device description
"""300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory 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
LJOAntigen, Iha, Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJOAntigen, Iha, CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001767000DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.2000-08-07LJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020020008172730200208172730200200817273020020

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay 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
305-324-2300Customersupport@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
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
00817273020198Diamedix720-3602016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817273020013DiamedixDIAMEDIX CORPORATIONLJO2016-09-20
00817273020167DiamedixDIAMEDIX CORPORATIONLJO2016-09-20
10888234001157Capture-CMVIMMUCOR, INC.LJO2016-04-14
10888234001232Capture-CMV Indicator Red CellsIMMUCOR, INC.LJO2016-04-14
10888234001249Capture-CMV Control setIMMUCOR, INC.LJO2016-04-14
10888234002154Capture-CMVIMMUCOR, INC.LJO2016-04-14