AccessGUDID - DEVICE: VERSANT HCV 2.0 LiPA (00630414000497)

GUDID

Device Identifier (DI) Information

Brand Name: VERSANT HCV 2.0 LiPA
Version or Model: 10719666
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10719666
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414000497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping

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):	Yes
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?
48374	Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBF	Assay, genotyping, hepatitis c virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160016	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b3a8b0c4-8b18-4d90-8d14-73fb5fb698a7
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 15, 2017