DEVICE: George King B-FACT (00815696020573)

Device Identifier (DI) Information

George King B-FACT
0040-1.5
Not in Commercial Distribution

GEORGE KING BIO-MEDICAL, INC
00815696020573
GS1
April 01, 2023
1
066761271 *Terms of Use
George King B-FACT is a borderline normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.
CLOSE

Device Characteristics

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

FDA Product Code

[?]
Product Code Product Code Name
GGN Plasma, Coagulation Control
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K945854 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: -70 C or below
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

cd3f7f85-812a-4b1d-948c-3f98e1ccde89
April 03, 2023
5
August 17, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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