FDA.reportPublic FDA data

Anti-M2-3E ELISA (IgG)

Primary DI
04049016027157
Brand
Anti-M2-3E ELISA (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EA 1622-9601 G
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K092736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092736000EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.2010-09-02DBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016027157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016027157040490160271574049016027157

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

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
00845714002502Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DBM2017-09-07
00845714002526Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DBM2017-09-07
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