DEVICE: Trinity Biotech (05391516741552)

Device Identifier (DI) Information

Trinity Biotech
345-A
In Commercial Distribution
345-A
TRINITY BIOTECH PUBLIC LIMITED COMPANY
05391516741552
GS1

1
988298840 *Terms of Use
Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (20 Tests)
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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
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen, using an enzyme spectrophotometry method.
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FDA Product Code

[?]
Product Code Product Code Name
JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K790211 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: 20 Tests
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Device Record Status

1be39f5e-2cb4-4053-a7b2-9904145de3aa
July 06, 2018
3
August 01, 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

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