FDA.reportPublic FDA data

Immco Diagnostics, Inc.

Primary DI
00845714002502
Brand
Immco Diagnostics, Inc.
Company
IMMCO DIAGNOSTICS, INC.
Model
5163G
Catalog number
5163G
Device description
AMA-M2 IgG ELISA
Published
2017-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163133000ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.2017-08-08DBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714002502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714002502008457140025028457140025020845714002502

GMDN Terms#

Term, Definition table
TermDefinition
Mitochondrial antibody M2 (anti-Mi2) 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 one or multiple antibodies to mitochondria M2 (anti-Mi2) 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
No natural rubber latex
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
07333066013206EliA Sample DiluentPhadia ABDBM2020-12-09
07333066020402EliA Sample DiluentPhadia ABDBM2020-12-09
07333066014333EliA M2 Positive Control 2500/5000Phadia ABDBM2020-12-09
00813545026608MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026615MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026622MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026639MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026950MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
00813545026967MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
00813545026974MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
00813545026981MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
08426950730101QUANTA Flash® M2 (MIT3) ReagentsINOVA DIAGNOSTICS, INC.DBM2018-01-26
00845714002526Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DBM2017-09-07
04049016027157Anti-M2-3E ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
04049016124887EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
04049016124894EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
07333066014852EliA M2 WellPhadia ABDBM2016-09-23
07333066010908EliA M2 WellPhadia ABDBM2016-09-23
05391516743839Trinity BiotechCLARK LABORATORIES, INC.DBM2016-09-22
00813545022273MA(RK)48 Test(L) SCIMEDX CORPORATIONDBM2016-09-19
00813545022297MA(RK)96 Test(L) SCIMEDX CORPORATIONDBM2016-09-19
00813545022303MA MS KDYTest(L) 48 TestSCIMEDX CORPORATIONDBM2016-09-19
00813545022310MA MS KDY Test(L) 96 TestSCIMEDX CORPORATIONDBM2016-09-19
00813545020279R. KDY Pack 8 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020286M. KDY Pack 4 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020293R. KDY Pack 4 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020309M. KDY Pack 8 WELLSCIMEDX CORPORATIONDBM2016-09-13
00847817016257KallestadBIO-RAD LABORATORIES, INC.DBM2016-09-12
00847865001205KallestadBio-RAD Laboratories, Inc.DBM2016-09-12
00847865001588KallestadBio-RAD Laboratories, Inc.DBM2016-09-12