FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714002960
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
5308
Catalog number
5308
Device description
Serum Diluent
Published
2016-10-27
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
DHRSystem, Test, Rheumatoid Factor
LLLExtractable Antinuclear Antibody, Antigen And Control
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
MSTAntibodies, Gliadin
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHRSystem, Test, Rheumatoid FactorImmunology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2
MSTAntibodies, GliadinImmunology2
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714002960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714002960008457140029608457140029600845714002960

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.

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
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
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
07333066024240EliA IgA Calibrator WellPhadia ABMVM2026-01-29
07333066024325EliA RF IgM WellPhadia ABDHR2026-01-29
07333066024332EliA RF IgA WellPhadia ABDHR2026-01-29
04049016161592IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161608IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161615IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161622IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
00845533002011Endomysium (Primate esophagus)ZEUS SCIENTIFIC, INC.MVM2025-10-17
08059304340239dIFine ANCA ClassifierVISIA LAB SRLMOB2025-06-27
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
07333066013138EliA IgM Conjugate 200Phadia ABDHR2021-04-30
00816426021457K-ASSAY® RF Reagent (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCDHR2020-11-03
07333066016115EliA SymphonyS WellPhadia ABLLL2020-06-30
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MST2020-01-30
07333066019901ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066019918ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066019925ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066019819ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
08426950793182QUANTA Flash® HMGCR ReagentsINOVA DIAGNOSTICS, INC.LLL2018-10-31
04049016108535IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108542IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108559IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108566IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108634IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108641IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108658IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04