AccessGUDID - DEVICE: VERSANT® HCV RNA 3.0 ASSAY bDNA (00630414472386)

GUDID

Device Identifier (DI) Information

Brand Name: VERSANT® HCV RNA 3.0 ASSAY bDNA
Version or Model: 10333499
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2553870
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414472386
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HCV RNA 3.0 Assay (bDNA) US IVD (Box 1)

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?
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
MZP	Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Premarket Submission

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

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: 310ba59b-2302-4cc6-867b-80ce49c42b6d
Public Version Date: November 19, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2014