← Back to catalogue

Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Device Name
Handheld portable analyzer for Lipid and Glucose Testing, Blood Sample used is 40ul FDA UDI
Model / Reference
5701036 FDA UDI
Description
Handheld portable analyzer for Lipid and Glucose Testing, Blood Sample used is 40ul FDA UDI

Identifiers

Catalog Number
5701036 FDA UDI
Primary DI / UDI-DI
10304040080594 FDA UDI
FDA Product Code
LCP FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7470 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyser IVD, point-of-care

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI a3277d49-85a0-4666-a40e-21bf1f901b25 34 fields · synced May 30, 2026