AccessGUDID - DEVICE: ACCURUN® (00816784020369)

GUDID

Device Identifier (DI) Information

Brand Name: ACCURUN®
Version or Model: 2015-0079
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2015-0079
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00816784020369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106267123 *Terms of Use

Device Description: ACCURUN 127 Anti-Hepatitis Delta 1 x 1.0 mL

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):	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?
42104	Human T-cell lymphotrophic virus 2 (HTLV2) 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 human T-cell lymphotrophic virus 2 (HTLV2) nucleic acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DGQ	Whole Blood Plasma, Antigen, Antiserum, Control

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 8774f565-5fa1-4b7e-a7f3-711f224bfc5c
Public Version Date: August 03, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2018