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JAS Diagnostics

FDA UDI

Class II (US FDA UDI)

by Drew Scientific , Ltd.

Identity

Trade Name
JAS Diagnostics FDA UDI
Generic Name
High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry FDA UDI
Device Name
LIPID CALIBRATOR (1 x 3 mL) FDA UDI
Model / Reference
LIPS1-3 FDA UDI
Description
LIPID CALIBRATOR (1 x 3 mL) FDA UDI

Identifiers

Catalog Number
LIPS1-3 FDA UDI
Primary DI / UDI-DI
00817274022634 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry

JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drew Scientific , Ltd.

Sources (1)

  • FDA UDI ad610cb7-3569-4e91-a21e-9b4c8540aaf4 36 fields · synced May 30, 2026