DEVICE: Trinity Biotech (05391516743785)

Device Identifier (DI) Information

Trinity Biotech
2337470
In Commercial Distribution
2337470
CLARK LABORATORIES, INC.
05391516743785
GS1

1
623214079 *Terms of Use
Captia™ Scl-70
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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
Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to scleroderma-70 (anti-Scl-70) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code

[?]
Product Code Product Code Name
LLL Extractable Antinuclear Antibody, Antigen And Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K935418 000
No 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
Device Size Text, specify: 96 Tests
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Device Record Status

ad073681-f455-4ff3-bd4a-36a12777bcf6
July 06, 2018
3
September 22, 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

[?]
1-800-325-3424
Customerservice@trinityusa.com
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