AccessGUDID - DEVICE: ACCURUN® 365 Series 200 (00816784020901)

GUDID

Device Identifier (DI) Information

Brand Name: ACCURUN® 365 Series 200
Version or Model: 2020-0107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2020-0107
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00816784020901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106267123 *Terms of Use

Device Description: ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.

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):	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?
49047	West Nile virus nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from West Nile virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYZ	Kit, Test (Donors), For Bloodborne Pathogen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK060022	0

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 -80 and -65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb29cb44-16c2-4e15-a426-4af96d52c9b4
Public Version Date: March 28, 2022
Public Version Number: 2
DI Record Publish Date: August 24, 2020