AccessGUDID - DEVICE: ANA (HEp-2) Test System, 1800 Tests (B110AND1800I0)

GUDID

Device Identifier (DI) Information

Brand Name: ANA (HEp-2) Test System, 1800 Tests
Version or Model: AND-1800 I
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AND-1800 I
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110AND1800I0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 27, 2019
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:	No
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?
54808	Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K872845	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: 76c7fa5a-e63d-433f-aa62-fc38aa7bc175
Public Version Date: March 04, 2020
Public Version Number: 5
DI Record Publish Date: September 12, 2016