DEVICE: Trinity Biotech (05391516748896)

Device Identifier (DI) Information

Trinity Biotech
10-1502N
In Commercial Distribution
10-1502N
MARDX DIAGNOSTICS, INC.
05391516748896
GS1

1
154281349 *Terms of Use
Primate Adsorbed FITC Bulk Conjugate with Evan’s Blue, 4.0 mL
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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
Skeletal muscle antibody IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to skeletal muscle in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
MVU Reagents,Specific,Analyte
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

1e4d14a7-2ca2-4aa2-a5ca-7ec8b3d82cf3
March 29, 2018
2
September 18, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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