DEVICE: Trinity Biotech (05391516741927)

Download: XML | JSON

Device Identifier (DI) Information

Trinity Biotech
450-A
450-A
TRINITY BIOTECH PUBLIC LIMITED COMPANY
05391516741927
GS1
1
Bile Acids Kit
CLOSE

Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Total bile acid IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of total bile acids in a clinical specimen, using an enzyme spectrophotometry method.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWW Radioimmunoassay, Cholyglycine, Bile Acids
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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 16 x 10 and 4 x 5 mL
CLOSE

Device Status

In Commercial Distribution
September 23, 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

[?]
+35312769800
Clinicalchemistry.techsupport@trinitybiotech.com
CLOSE