FDA.reportPublic FDA data

MESACUP BP230 ELISA Kit

Primary DI
04987506015966
Brand
MESACUP BP230 ELISA Kit
Company
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Model
48 wells
Catalog number
7613US
Device description
The MESACUP BP230 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 230 antibodies in human serum. The MESACUP BP230 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.
Published
2020-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987506015966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987506015966049875060159664987506015966

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 Humidity2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8475445044nadine.shabat@aesku-bion.com

Regulatory Flags#

DUNS number
691688915
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
04987506015942DSG-1 & DSG-3 ELISA Test SystemDSG1 48 wells and DSG3 48 wells.7593US2020-02-17
04987506017434DSG-1 & DSG-3 ELISA Test SystemDSG1 48 wells and DSG3 48 wells.7594US2023-08-04
04987506015959MESACUP BP180 ELISA Kit48 wells7695US2020-02-17

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
04049016091608Anti-BP230-CF ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGOEG2020-09-28
04987506015959MESACUP BP180 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