AccessGUDID - DEVICE: 96AN (03610520560457)

GUDID

Device Identifier (DI) Information

Brand Name: 96AN
Version or Model: 96AN-BPU-TRINITY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 96AN-BPU-TRINITY
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 03610520560457
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884513334 *Terms of Use

Device Description: 96ANA BULK PACK UNLABELED, TRINITY

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:	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?
54811	Multiple antinuclear antibody (ANA) screening IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKJ	ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954723	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
Device Size Text, specify: Case

Device Record Status

Public Device Record Key: b1bd7be6-bcbd-4335-aae0-02020df9eab8
Public Version Date: July 29, 2021
Public Version Number: 5
DI Record Publish Date: September 12, 2016