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JAS Diagnostics

FDA UDI

Class I (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
HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) FDA UDI
Model / Reference
HDL4-250 FDA UDI
Description
HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) FDA UDI

Identifiers

Catalog Number
HDL4-250 FDA UDI
Primary DI / UDI-DI
00817274022856 FDA UDI
510(k) Number
K021671 FDA UDI
FDA Product Code
LBS FDA UDI
GMDN Term
High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1475 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

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

Similar devices

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

Cleared under the same submission

K021671 also covers:

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 158efa40-3d54-486e-94d3-bf711467a10a 37 fields · synced Jun 8, 2026