← Back to catalogue

CURO L5 TG test strip

FDA UDI

Class I (US FDA UDI)

by OSANG HEALTHCARE Co., Ltd.

Identity

Trade Name
CURO L5 TG test strip FDA UDI
Generic Name
Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid FDA UDI
Model / Reference
ILM-0001A FDA UDI

Identifiers

Primary DI / UDI-DI
08809115905444 FDA UDI
FDA Product Code
JGY FDA UDI
GMDN Term
Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1705 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

No

FDA UDI

Category: Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid

CURO L5 TG test strip by OSANG HEALTHCARE Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OSANG HEALTHCARE Co., Ltd.

Sources (1)

  • FDA UDI f576eaec-5360-4bee-8718-da670904064d 33 fields · synced Jun 1, 2026