DEVICE: Beckman Coulter PK TP System (04987270226964)

Device Identifier (DI) Information

Beckman Coulter PK TP System
226964
In Commercial Distribution
PH3000
FUJIREBIO INC.
04987270226964
GS1

1
710873907 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61225 Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KSZ System, Test, Automated Blood Grouping And Antibody
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK060062 0
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Size Type = Tests Per Kit; Size Unit = 3000; Unit of Measure = Tests
CLOSE

Device Record Status

58abf7ef-08a5-4ba5-a233-2cff6eafe09a
July 06, 2018
3
September 16, 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

[?]
800-223-0125
xx@xx.xx
800-447-5852
xx@xx.xx
CLOSE