FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020372
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
720-700
Device description
"""720-700 anti-dsDNA 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
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994424000DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMDiamedix Corp.2000-02-18LRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020372008172730203728172730203720817273020372

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, kitA collection of reagents and other associated materials intended to be used for the detection of nucleic acid (e.g., DNA, RNA) probes [not included] hybridized to their target nucleotide sequences in a clinical specimen. It may be based on different techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH), or line probe assay (LPA)] and is used to detect and localize the presence or absence of specific nucleic acid sequences.

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
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
00817273020198Diamedix720-3602016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840239034380Anti-dsDNA IgG ELISADRG International IncLRM2023-08-24
00840239035646Anti-dsDNA IgM ELISADRG International IncLRM2023-08-24
00840239035653Anti-dsDNA IgA ELISADRG International IncLRM2023-08-24
00840239035660Anti-dsDNA Screen ELISADRG International IncLRM2023-08-24
B3507207000Gold Standard Diagnostics Is-anti-dsDNA ELISA Test KitGold Standard Diagnostics CorporationLRM2022-12-02
04048474034387Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035643Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035650Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035667Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847434385Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435641Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435658Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435665Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-10-27
00816879020014Autostat II Anti-ds-DNAHYCOR BIOMEDICAL LLCLRM2016-09-26
04049016026884Anti-dsDNA-NcX ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLRM2016-09-24
05391516743723Trinity BiotechCLARK LABORATORIES, INC.LRM2016-09-22
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00847817007040Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817022364Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817022463Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865000086BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865001342BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12