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Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Urine analyser IVD, laboratory, semi-automated FDA UDI
Device Name
Urispec + UA Reader FDA UDI
Model / Reference
9007566 FDA UDI
Description
Urispec + UA Reader FDA UDI

Identifiers

Catalog Number
9007566 FDA UDI
Primary DI / UDI-DI
00304040001516 FDA UDI
FDA Product Code
KSL FDA UDI
JJB FDA UDI
JIL FDA UDI
JMA FDA UDI
LJX FDA UDI
JIN FDA UDI
JIR FDA UDI
CEN FDA UDI
JIP FDA UDI
CDM FDA UDI
JMT FDA UDI
GMDN Term
Urine analyser IVD, laboratory, semi-automated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.9320 FDA UDI
862.1115 FDA UDI
862.1340 FDA UDI
862.1095 FDA UDI
864.7675 FDA UDI
862.1435 FDA UDI
862.1645 FDA UDI
862.1550 FDA UDI
864.6550 FDA UDI
862.1785 FDA UDI
862.1510 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Urine analyser IVD, laboratory, semi-automated

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

Similar devices

Also classified as Urine analyser IVD, laboratory, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI b687b7da-4751-4384-b4b4-e52ec95e407e 35 fields · synced May 31, 2026