AccessGUDID - DEVICE: ELITe InGenius® SP 200 (03661540900020)

GUDID

Device Identifier (DI) Information

Brand Name: ELITe InGenius® SP 200
Version or Model: INT032SP200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INT032SP200
Company Name: ELITECHGROUP SPA

Primary DI Number: 03661540900020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 434528644 *Terms of Use

Device Description: The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection. ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&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: 23b8c9af-326f-44f6-8b9c-792a3253798c
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 09, 2019