DEVICE: FREND (08809317540535)
Device Identifier (DI) Information
FREND
FREND PSA Plus Linearity Kit
In Commercial Distribution
FLK-PSA
NanoEnTek, Inc.
FREND PSA Plus Linearity Kit
In Commercial Distribution
FLK-PSA
NanoEnTek, Inc.
FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only.
FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Non-blood cell primer/calibrator/control material IVD, reagent | A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen. |
FDA Product Code
[?]Product Code | Product Code Name |
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JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5f309a29-3466-415f-a681-6af75b5b4a25
November 04, 2020
2
October 01, 2018
November 04, 2020
2
October 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined