FDA.reportPublic FDA data

Anti-BP230-CF ELISA (IgG)

Primary DI
04049016091608
Brand
Anti-BP230-CF ELISA (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EA 1502-4801-1 G
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193115000EUROIMMUN Anti-BP230-CF ELISA (IgG)Euroimmun Us, Inc.2020-09-17OEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016091608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016091608040490160916084049016091608

GMDN Terms#

Term, Definition table
TermDefinition
Bullous pemphigoid antigen 1 (BPAG1) antibody 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 bullous pemphigoid antigen 1 (BPAG1), also known as BP230, in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune skin disease bullous pemphigoid.

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
10197106496145CARDINAL HEALTHCardinal Health 200, LLCOEG2023-12-08
50197106496143CARDINAL HEALTHCardinal Health 200, LLCOEG2023-12-08
10197106398050CARDINAL HEALTHCardinal Health 200, LLCOEG2023-11-09
50197106398058CARDINAL HEALTHCardinal Health 200, LLCOEG2023-11-09
04987506015959MESACUP BP180 ELISA KitMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.OEG2020-02-17
04987506015966MESACUP BP230 ELISA KitMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.OEG2020-02-17
04049016026839Anti-BP180-NC16A-4X ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGOEG2016-09-24
B110RGM7612D0BP 180 ELISA TESTBion Enterprises, Ltd.OEG2016-09-12
B110RGM7613D0BP 230 ELISA TESTBion Enterprises, Ltd.OEG2016-09-12