AccessGUDID - DEVICE: Biomeme RNA Process Control (RPC) Kiit (00810096640079)

GUDID

Device Identifier (DI) Information

Brand Name: Biomeme RNA Process Control (RPC) Kiit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3000627
Company Name: Biomeme, Inc.

Primary DI Number: 00810096640079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 079110357 *Terms of Use

Device Description: RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)

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?
60094	Exogenous DNA/RNA internal control IVD, kit	A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid

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: 0f8f9c07-0aaf-4c3b-bb56-ffe2c3977ee5
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022