AccessGUDID - DEVICE: Helix Elite™ Molecular Standards: Synthetic Standard (10845357041736)

GUDID

Device Identifier (DI) Information

Brand Name: Helix Elite™ Molecular Standards: Synthetic Standard
Version or Model: HE0001S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HE0001S
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10845357041736
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 060467826 *Terms of Use

Device Description: Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA

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?
61060	Multiple-type gastrointestinal pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative and/or qualitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.	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: 14500ea1-920a-47b7-bf8e-d61a78d6025c
Public Version Date: September 27, 2022
Public Version Number: 4
DI Record Publish Date: April 30, 2020