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Leakbuster

FDA UDI

Class I (US FDA UDI)

by Starplex Scientific, Inc.

Identity

Trade Name
Leakbuster FDA UDI
Generic Name
Drug-testing urine specimen container IVD FDA UDI
Device Name
Specimen Container, 90 ml Wide Mouth, Orange Cap, Applied Temperature Strip, Non-Sterile FDA UDI
Model / Reference
WB902-1ONTS FDA UDI
Description
Specimen Container, 90 ml Wide Mouth, Orange Cap, Applied Temperature Strip, Non-Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
10840165500161 FDA UDI
FDA Product Code
NNI FDA UDI
GMDN Term
Drug-testing urine specimen container IVD 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Drug-testing urine specimen container IVD

Leakbuster by Starplex Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drug-testing urine specimen container IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Starplex Scientific, Inc.

Sources (1)

  • FDA UDI 26baad5d-1a49-4fc5-9d5b-d441079395e6 33 fields · synced May 31, 2026