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Busulfan Level 1

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name
BUSULFAN LEVEL 1 FDA UDI
Generic Name
Busulfan therapeutic drug monitoring IVD, control FDA UDI
Device Name
BUSULFAN LEVEL 1 FDA UDI
Model / Reference
BUS 1 P F UK FDA UDI
Description
BUSULFAN LEVEL 1 FDA UDI

Identifiers

Primary DI / UDI-DI
B80001696000070 FDA UDI
FDA Product Code
LAS FDA UDI
GMDN Term
Busulfan therapeutic drug monitoring IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3280 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

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Busulfan therapeutic drug monitoring IVD, control

Busulfan Level 1 by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Busulfan therapeutic drug monitoring IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utak Laboratories, Inc.

Sources (1)

  • FDA UDI bcf536b7-e6f3-4194-be64-81a197e16f2a 34 fields · synced Jun 1, 2026