DEVICE: George King SysCOR Plus Kit (00815696020498)

Device Identifier (DI) Information

George King SysCOR Plus Kit
0065-35
Not in Commercial Distribution

GEORGE KING BIO-MEDICAL, INC
00815696020498
GS1
April 01, 2023
1
066761271 *Terms of Use
SysCOR Plus 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. Similar to the SysCOR kit but with five additional Coumadin® control plasmas.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
GGN Plasma, Coagulation Control
GGC Control, Plasma, Abnormal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

7a9a67b5-5639-4f7b-8921-229a68b417ba
April 03, 2023
4
August 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-255-5108
plasma@kingbiomed.com
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