AccessGUDID - DEVICE: Genemed® (00615233007827)

GUDID

Device Identifier (DI) Information

Brand Name: Genemed®
Version or Model: 60-0208-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-0208-15
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233007827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: anti-Herpes Simplex Virus 2 (HSV2) Rabbit Polyclonal Antibody, Ready-To-Use, 15 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?
63747	Herpes simplex virus 2 (HSV2) antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 2 (HSV2) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, specific, analyte

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 105a08d0-87e2-4772-8f8d-742509765e5a
Public Version Date: July 01, 2020
Public Version Number: 1
DI Record Publish Date: June 23, 2020