FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714003943
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
2250
Catalog number
2250
Device description
EMA Positive Control
Published
2016-09-23
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
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, ControlImmunology2
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060157000
K912551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060157000IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFAImmco Diagnostics, Inc.2006-05-25MVM
K912551000ANTI-ENDOMYSIAL ANTIBODY TESTImmco Diagnostics, Inc.1993-06-09DBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714003943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714003943008457140039438457140039430845714003943

GMDN Terms#

Term, Definition table
TermDefinition
Endomysium antibody (EMA) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066024240EliA IgA Calibrator WellPhadia ABMVM2026-01-29
07333066023977EliA IgA Calibrator WellPhadia ABMVM2026-01-29
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
04049016144595IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2024-05-17
00813545029029GBM IgG Test SystemSCIMEDX CORPORATIONDBL2023-06-13
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
07333066014180EliA Celiac Positive Control 2500/5000Phadia ABMVM2020-12-09
00813545026684MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026691MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
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00813545026776MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
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00813545026813MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
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00813545026837MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026844MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026851MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026868MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026875MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026882MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
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