HDL Cholesterol Verifier Kit

FDA UDI

Class II (US FDA UDI)

by Verichem Laboratories, Inc.

Identity

Trade Name: HDL Cholesterol Verifier Kit FDA UDI
Generic Name: Total cholesterol lipid IVD, calibrator FDA UDI
Model / Reference: 9560 FDA UDI

Identifiers

Primary DI / UDI-DI: 00852553007025 FDA UDI
510(k) Number: K924904 FDA UDI
FDA Product Code: JIS FDA UDI
GMDN Term: Total cholesterol lipid IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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

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

Dimensions & Sizes

Size: Total Volume — 30 Milliliter FDA UDI

Category: Total cholesterol lipid IVD, calibrator

HDL Cholesterol Verifier Kit by Verichem Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Total cholesterol lipid IVD, calibrator.

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POINTE SCIENTIFIC Cholesterol Standard — POINTE SCIENTIFIC, INC. · Class I
Direct (HDL/LDL) Cholesterol Calibrator — STANBIO LABORATORY, L.P. · Class I
Dimension® CHOL Calibrator — Siemens Healthcare Diagnostics · Class II
Matrix Plus Cholesterol, Level F — VERICHEM LABORATORIES, INC. · Class II
Cholesterol Reference Kit — VERICHEM LABORATORIES, INC. · Class II

Cleared under the same submission

K924904 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 II	Pending data

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Manufacturer

Manufacturer: Verichem Laboratories, Inc.

Sources (1)

FDA UDI 68823e77-00d1-4504-afc1-b57869a258f2 35 fields · synced Jun 6, 2026