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US Urine Examiner Kit

FDA UDI

Class I (US FDA UDI)

by Quest Diagnostics

Identity

Trade Name
US Urine Examiner Kit FDA UDI
Generic Name
Specimen container mailer, insulated FDA UDI
Device Name
US Urine Examiner Kit FDA UDI
Model / Reference
Exempt FDA UDI
Description
US Urine Examiner Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850054552051 FDA UDI
FDA Product Code
OIE FDA UDI
GMDN Term
Specimen container mailer, insulated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Specimen container mailer, insulated

US Urine Examiner Kit by Quest Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Specimen container mailer, insulated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quest Diagnostics

Sources (1)

  • FDA UDI 5e8ee0d5-c747-45cc-81e5-3b713e571e8e 34 fields · synced May 31, 2026