Triglycerides

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Triglycerides FDA UDI
Generic Name: Triglyceride IVD, kit, spectrophotometry FDA UDI
Model / Reference: 20767107322 FDA UDI

Identifiers

Catalog Number: 20767107322 FDA UDI
Primary DI / UDI-DI: 04015630918393 FDA UDI
510(k) Number: K873049 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Triglycerides by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K873049 also covers:

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: Roche Diagnostics Corp.

Sources (1)

FDA UDI 6dfdca10-7356-44f8-ba74-7105d1453ed9 34 fields · synced May 30, 2026