AccessGUDID - DEVICE: DC-TROL Level 2 (00628063400461)

GUDID

Device Identifier (DI) Information

Brand Name: DC-TROL Level 2
Version or Model: SM-056
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SM-056
Company Name: SEKISUI DIAGNOSTICS, LLC

Primary DI Number: 00628063400461
Issuing Agency: GS1
Commercial Distribution End Date: July 14, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 966812344 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	Yes
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?
47869	Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K874772	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: 2af18858-ff44-4a7e-8ea5-9d9adf5334c4
Public Version Date: July 24, 2024
Public Version Number: 5
DI Record Publish Date: September 20, 2016