DEVICE: Bartels® (05391516745161)

Device Identifier (DI) Information

Bartels®
B1029-81A
In Commercial Distribution
B1029-81A
TRINITY BIOTECH PUBLIC LIMITED COMPANY
05391516745161
GS1

1
988298840 *Terms of Use
Bartels® Cytomegalovirus Fluorescent Antibody Reagent
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Cytomegalovirus (CMV) antigen 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 antigens from cytomegalovirus (CMV) in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K894002 000
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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: 50-100 Tests
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Device Record Status

455a49b4-5597-46f5-ac6d-ced28bd1b48c
July 06, 2018
3
September 23, 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
Infectiousdisease.techsupport@trinitybiotech.com
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