DEVICE: Validate (00859110005869)

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Device Record History
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Device Identifier (DI) Information
Validate
507ro
In Commercial Distribution
507ro
Lgc Clinical Diagnostics, Inc.
00859110005869
GS1

1
075886031 *Terms of Use
Validate LP2 is intended for the quantitative determination of Calibration Verification/Linearity 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© 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?
41809 Apolipoprotein A-I (Apo A1) IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen.
Active false
41813 Apolipoprotein B (Apo B) IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of apolipoprotein B (Apo B) lipid in a clinical specimen.
Active false
30214 Multiple lipid analyte IVD, control
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JJY Multi-Analyte Controls, All Kinds (Assayed)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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 -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 Record Status
ad282051-a58d-48ad-89a6-53d4802ae944
December 08, 2022
3
March 02, 2020
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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
MSC.info@LGCGroup.com
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