DEVICE: AimStrip Tandem Lipid Profile and glucose measuring system (00695684773014)

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Device Identifier (DI) Information
AimStrip Tandem Lipid Profile and glucose measuring system
ILM-0001A
In Commercial Distribution

GERMAINE LABORATORIES, INC
00695684773014
GS1

1
176458115 *Terms of Use
Lipid and Glucose Measuring System
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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?
52849 Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence
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 chemiluminescence method.
Obsolete false
53303 Glucose IVD, kit, electrometry
A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.
Active false
41819 Glucose IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
Active false
53359 Total cholesterol lipid IVD, kit, spectrophotometry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method.
Active false
44697 Total cholesterol lipid IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total cholesterol lipid in a clinical specimen.
Active false
44701 Triglyceride IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of triglycerides in a clinical specimen.
Active false
53460 Triglyceride IVD, kit, spectrophotometry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of triglycerides in a clinical specimen, using a spectrophotometry method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CGA Glucose Oxidase, Glucose
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
CHH Enzymatic Esterase--Oxidase, Cholesterol
JGY Colorimetric Method, Triglycerides
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
4efcb199-ffff-49f3-97c5-f29659b56c41
November 11, 2024
4
March 13, 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
Yes
No
No
No CLOSE

Customer Contact

[?]
1-800-854-8446
sales@germainelabs.com
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