AccessGUDID - DEVICE: Helix Elite™ Molecular Standards: Inactivated Standard (10845357043952)

GUDID

Device Identifier (DI) Information

Brand Name: Helix Elite™ Molecular Standards: Inactivated Standard
Version or Model: HE0074NS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HE0074NS
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10845357043952
Issuing Agency: GS1
Commercial Distribution End Date: May 14, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 060467826 *Terms of Use

Device Description: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 B.1.351 Whole Virus (Swab)

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?
64748	SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen.	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: 6801c04f-f47f-47e1-91cf-4b2df6c69d15
Public Version Date: May 15, 2025
Public Version Number: 2
DI Record Publish Date: February 16, 2022