AccessGUDID - DEVICE: ELITe InGenius® SP 200 Consumable Set (03661540900044)

GUDID

Device Identifier (DI) Information

Brand Name: ELITe InGenius® SP 200 Consumable Set
Version or Model: INT032CS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP SPA

Primary DI Number: 03661540900044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 434528644 *Terms of Use

Device Description: The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection. ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay

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:	Yes
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?
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	Real Time Nucleic Acid Amplification System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180559	000

Device Exempt from Premarket Submission: No 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: 0e292826-8af3-49e2-bfbd-2a2c78760131
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 10, 2019