AccessGUDID - DEVICE: BP 180 ELISA TEST (B110RGM7612D0)

GUDID

Device Identifier (DI) Information

Brand Name: BP 180 ELISA TEST
Version or Model: RG-M7612-D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RG-M7612-D
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110RGM7612D0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 07, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 024824641 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	Yes
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?
62294	Bullous pemphigoid antigen 2 (BPAG2) 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 2 (BPAG2), also known as BP180, 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 [?]
K071961	000

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 Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51c710df-0bdb-4fbc-a41c-4e1036af0cda
Public Version Date: April 09, 2020
Public Version Number: 5
DI Record Publish Date: September 12, 2016