AccessGUDID - DEVICE: George King SysCOR Kit (00815696020481)

GUDID

Device Identifier (DI) Information

Brand Name: George King SysCOR Kit
Version or Model: 0065-30
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696020481
Issuing Agency: GS1
Commercial Distribution End Date: March 20, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: SysCOR is a System Control convenience kit which contains different levels of control material that can be used to correlate results when changing lot numbers of reagents and/or instrument platforms.

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):	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?
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGN	Plasma, Coagulation Control
GGC	Control, Plasma, Abnormal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: -70 degrees or below

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58374ac8-edad-497e-a10a-5b7b9504a198
Public Version Date: March 20, 2020
Public Version Number: 4
DI Record Publish Date: August 19, 2016