AccessGUDID - DEVICE: QC Sets and Panels: Helix Elite™ (70845357043732)

GUDID

Device Identifier (DI) Information

Brand Name: QC Sets and Panels: Helix Elite™
Version or Model: 8249
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8249
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 70845357043732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060467826 *Terms of Use

Device Description: QC Sets and Panels: Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel

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:	Yes
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?
48210	Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of pathogens associated with vaginitis and/or vaginosis in a clinical specimen. Pathogens intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55c5a0fc-d0a2-4346-9254-19ad21ac3f7b
Public Version Date: May 09, 2025
Public Version Number: 3
DI Record Publish Date: February 16, 2022