DEVICE: CURO L7 Lipid Test Strip - Lipid Profile (08809319396512)

Device Identifier (DI) Information

CURO L7 Lipid Test Strip - Lipid Profile
99LS10-2
In Commercial Distribution

SD Biosensor, Inc.
08809319396512
GS1

10
557812789 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
52850 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.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
CHH Enzymatic Esterase--Oxidase, Cholesterol
JGY Colorimetric Method, Triglycerides
LBR Ldl & Vldl Precipitation, Hdl
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160282 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

00d7c67e-d212-4e0d-9b68-4c83e74253e0
April 29, 2020
1
April 21, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: 08809319396789 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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