DEVICE: Trinity Biotech (05391516747899)

Download: XML | JSON

Device Identifier (DI) Information

Trinity Biotech
40-6196P
40-6196P
MARDX DIAGNOSTICS, INC.
05391516747899
GS1
1
B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Bordetella pertussis total antibody IVD, kit, immunoblot A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Bordetella pertussis in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GOX Antigen, B. Pertussis
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
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 18, 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

[?]
800-325-3424
info@trinitybiotech.com
CLOSE