AccessGUDID - DEVICE: VERSANT® Sample Preparation 1.2 Reagents (Box 1) (00630414587134)

GUDID

Device Identifier (DI) Information

Brand Name: VERSANT® Sample Preparation 1.2 Reagents (Box 1)
Version or Model: 10629800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10629800
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414587134
Issuing Agency: GS1
Commercial Distribution End Date: September 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: VERSANT® Sample Preparation 1.2 Reagents (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:	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?
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	CLINICAL SAMPLE CONCENTRATOR

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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 106162b7-5bc0-42a6-9462-76c1df46f302
Public Version Date: September 08, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2018