FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714001888
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
5120
Catalog number
5120
Device description
dsDNA Antibody ELISA
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714001888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714001888008457140018888457140018880845714001888

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) 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 antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
1-800-537-8378INFO@IMMCO.COM

Regulatory Flags#

DUNS number
079935300
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845714000003IMMCO DIAGNOSTICS110211022016-09-21
00845714000010IMMCO DIAGNOSTICS110311032016-09-21
00845714000089IMMCO DIAGNOSTICS113611362016-09-21
00845714000096IMMCO DIAGNOSTICS1136-961136-962016-09-21
00845714000218IMMCO DIAGNOSTICS117511752016-09-21
00845714000249IMMCO DIAGNOSTICS 1102-601102-602016-09-21
00845714000287IMMCO DIAGNOSTICS110711072016-09-21
00845714000393IMMCO DIAGNOSTICS112511252016-09-21
00845714000430IMMCO DIAGNOSTICS113411342016-09-21
00845714000461IMMCO DIAGNOSTICS1136-2501136-2502016-09-21
00845714000829IMMCO DIAGNOSTICS1102-1201102-1202016-09-21
00845714000836IMMCO DIAGNOSTICS1102-120X1102-120X2016-09-21
00845714000843IMMCO DIAGNOSTICS1102-60X1102-60X2016-09-21
00845714000867IMMCO DIAGNOSTICS 1102X1102X2016-09-21
00845714000874IMMCO DIAGNOSTICS1103-2401103-2402016-09-21
00845714000881IMMCO DIAGNOSTICS 1103-240X1103-240X2016-09-21
00845714000898IMMCO DIAGNOSTICS1103-4801103-4802016-09-21
00845714000904IMMCO DIAGNOSTICS1103-480X1103-480X2016-09-21
00845714000928IMMCO DIAGNOSTICS1103X1103X2016-09-21
00845714001017IMMCO DIAGNOSTICS1107-11107-12016-09-21

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
00817273020372DiamedixDIAMEDIX CORPORATIONLRM2016-09-20
05391516747141Trinity BiotechCLARK LABORATORIES, INC.LRM2016-09-19
00847817006937Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817007033Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
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