Triglyceride-Sl

FDA UDI

Class I (US FDA UDI)

by Sekisui Diagnostics, LLC

Identity

Trade Name: TRIGLYCERIDE-SL FDA UDI
Generic Name: Triglyceride IVD, kit, spectrophotometry FDA UDI
Model / Reference: 236-99 FDA UDI

Identifiers

Catalog Number: 236-99 FDA UDI
Primary DI / UDI-DI: 00628063400904 FDA UDI
510(k) Number: K961281 FDA UDI
FDA Product Code: CDT FDA UDI
GMDN Term: Triglyceride IVD, kit, spectrophotometry 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Triglyceride IVD, kit, spectrophotometry

Triglyceride-Sl by Sekisui Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Triglyceride IVD, kit, spectrophotometry.

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AimStrip Tandem Total Triglycerides Test Strips — GERMAINE LABORATORIES, INC. · Class I
Triglycerides — Roche Diagnostics Corp. · Class I
ABX PENTRA TRIGLYCERIDES CP — Horiba Abx · Class I
ADVIA® Chemistry TRIG_c Reagent — Siemens Healthcare Diagnostics · Class I
Dimension Vista® Flex® reagent cartridge TRIG — Siemens Healthcare Diagnostics · Class I
TRIGLYCERIDES SL — VITALSCIENTIFIC
Triglycerides/Glycerol Blanked — Roche Diagnostics Corp. · Class I

Cleared under the same submission

K961281 also covers:

TRIGLYCERIDE-SL — Sekisui Diagnostics, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sekisui Diagnostics, LLC

Sources (1)

FDA UDI 8a3b9ac2-546c-40e8-b6dc-889d39f91bc6 34 fields · synced Jun 9, 2026