FDA.report

BUSULFAN LEVEL 4

Primary DI
B800BUS4VDPFDU5
Brand
BUSULFAN LEVEL 4
Company
UTAK LABORATORIES, INC.
Model
BUS 4 V DP F DU
Catalog number
BUS 4 V DP F DU
Device description
BUSULFAN LEVEL 4
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LASDrug Specific Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B800BUS4VDPFDU5PackageHIBCC25In Commercial Distribution
B800BUS4VDPFDU0PrimaryHIBCC0

GMDN Terms

TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume1Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-882-5522welovecontrol@utak.com

Regulatory Flags

DUNS number
092519016
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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