AccessGUDID - DEVICE: MESACUP BP230 ELISA Kit (04987506015966)

GUDID

Device Identifier (DI) Information

Brand Name: MESACUP BP230 ELISA Kit
Version or Model: 48 wells
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7613US
Company Name: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.

Primary DI Number: 04987506015966
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691688915 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62295	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEG	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1b500eb-0911-41f2-93e1-40881131ad72
Public Version Date: July 27, 2023
Public Version Number: 3
DI Record Publish Date: February 17, 2020