DEVICE: Alere Cholestech LDX® (04571226470831)

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Device Identifier (DI) Information

Alere Cholestech LDX®
14-531
14-531
ALERE SAN DIEGO, INC.
04571226470831
GS1
1
Alere Cholestech LDX® Lipid Profile●GLU
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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
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using an enzyme spectrophotometry method.
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FDA Product Code

[?]
Product Code Product Code Name
CGA Glucose Oxidase, Glucose
JGY Colorimetric Method, Triglycerides
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
CHH Enzymatic Esterase--Oxidase, Cholesterol
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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
No Device Sizes
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Device Status

In Commercial Distribution
June 29, 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
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+18773088289
USproductsupport@alere.com
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