DEVICE: μTASWako DCP Calibrator Set (00856626006212)

Download: XML | JSON

Device Identifier (DI) Information

μTASWako DCP Calibrator Set
999-61201
999-61201
WAKO LIFE SCIENCES, INC.
00856626006212
GS1
1
In-Vitro Diagnostic Use
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Des-gamma-carboxyprothrombin (DCP) IVD, calibrator A material used to establish known points of reference for an assay intended to qualitatively and/or quantitatively detect des-gamma-carboxyprothrombin (DCP) [protein induced by vitamin K absence-II (PIVKA-II)] in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JIT Calibrator, Secondary
CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
November 25, 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

[?]
877-714-1924
diagnostics@wakousa.com
CLOSE