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Leakbuster

FDA UDI

Class I (US FDA UDI)

by Starplex Scientific, Inc.

Identity

Trade Name
Leakbuster FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
Specimen Container, 120 ml, White Cap, Individually Packaged in Peel Pack, Sterile. FDA UDI
Model / Reference
B1202-1W-OR FDA UDI
Description
Specimen Container, 120 ml, White Cap, Individually Packaged in Peel Pack, Sterile. FDA UDI

Identifiers

Primary DI / UDI-DI
00840165500379 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
General specimen container IVD, no additive/medium 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

Yes

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: General specimen container IVD, no additive/medium

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

Similar devices

Also classified as General specimen container IVD, no additive/medium.

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 124b562d-4671-40ac-8361-3f59d0b2e60f 33 fields · synced Jun 8, 2026