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CURO L7 Lipid Test Strip - Lipid Profile

FDA UDI

Class I (US FDA UDI)

by Sd Biosensor

Identity

Trade Name
CURO L7 Lipid Test Strip - Lipid Profile FDA UDI
Generic Name
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry FDA UDI
Model / Reference
99LS10-2 FDA UDI

Identifiers

Primary DI / UDI-DI
08809319396512 FDA UDI
510(k) Number
K160282 FDA UDI
FDA Product Code
CHH FDA UDI
JGY FDA UDI
LBR FDA UDI
GMDN Term
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1175 FDA UDI
862.1705 FDA UDI
862.1475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

CURO L7 Lipid Test Strip - Lipid Profile by Sd Biosensor — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry.

Cleared under the same submission

K160282 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sd Biosensor

Sources (1)

  • FDA UDI 00d7c67e-d212-4e0d-9b68-4c83e74253e0 33 fields · synced Jun 6, 2026