DEVICE: Valproic Acid ONLINE TDM Valproic Acid (04015630997954)

Device Identifier (DI) Information

Valproic Acid ONLINE TDM Valproic Acid
4642465190
Not in Commercial Distribution
4642465190
Roche Diagnostics GmbH
04015630997954
GS1
May 01, 2019
1
315028860 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59053 Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug valproic acid in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LEG ENZYME IMMUNOASSAY, VALPROIC ACID
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K060690 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

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Size Type Text
No Device Sizes
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Device Record Status

61816322-f4d3-4da4-9180-fa44e2778e01
November 11, 2020
4
September 20, 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

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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

[?]
No Customer Contact currently defined
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