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.
99LS10-2
In Commercial Distribution
SD Biosensor, Inc.
No description.
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.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHH | Enzymatic Esterase--Oxidase, Cholesterol |
JGY | Colorimetric Method, Triglycerides |
LBR | Ldl & Vldl Precipitation, Hdl |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160282 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
00d7c67e-d212-4e0d-9b68-4c83e74253e0
April 29, 2020
1
April 21, 2020
April 29, 2020
1
April 21, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
08809319396789
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined