BUSULFAN LEVEL 1

GUDID B80001696000071

Busulfan therapeutic drug monitoring IVD, control

Primary Device ID	B80001696000071
NIH Device Record Key	bcf536b7-e6f3-4194-be64-81a197e16f2a
Commercial Distribution Status	In Commercial Distribution
Brand Name	BUSULFAN LEVEL 1
Version Model Number	BUS 1 P F UK
Company DUNS	092519016
Company Name	UTAK LABORATORIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B80001696000070 [Primary]
HIBCC	B80001696000071 [Package] Contains: B80001696000070 Package: Box [4 Units] In Commercial Distribution
HIBCC	B80001696000072 [Package] Contains: B80001696000070 Package: Box [5 Units] In Commercial Distribution
HIBCC	B80001696000073 [Package] Contains: B80001696000070 Package: Box [10 Units] In Commercial Distribution
HIBCC	B80001696000076 [Package] Contains: B80001696000070 Package: Box [25 Units] In Commercial Distribution
HIBCC	B80001696000077 [Package] Contains: B80001696000070 Package: Box [50 Units] In Commercial Distribution
HIBCC	B80001696000078 [Package] Contains: B80001696000070 Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false