DEVICE: Validate (00859110005036)

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Device Identifier (DI) Information

Validate
301db
301db
MAINE STANDARDS COMPANY, LLC
00859110005036
GS1
1
Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
Multiple therapeutic drugs/drugs of abuse IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
DKB Calibrators, Drug Mixture
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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 -25 and -10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 2 tests
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Device Status

In Commercial Distribution
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

[?]
1-800-377-9684
info@mainestandards.com
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