FDA.reportPublic FDA data

BUSULFAN LEVEL 1

Primary DI
B80001696000070
Brand
BUSULFAN LEVEL 1
Company
UTAK LABORATORIES, INC.
Model
BUS 1 P F UK
Device description
BUSULFAN LEVEL 1
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B80001696000071PackageHIBCC4In Commercial Distribution
B80001696000072PackageHIBCC5In Commercial Distribution
B80001696000073PackageHIBCC10In Commercial Distribution
B80001696000076PackageHIBCC25In Commercial Distribution
B80001696000077PackageHIBCC50In Commercial Distribution
B80001696000078PackageHIBCC100In Commercial Distribution
B80001696000070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Busulfan 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 the antineoplastic drug busulfan in a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
+1(888) 882-5522welovecontrol@utak.com

Regulatory Flags#

DUNS number
092519016
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B800BUP5WBFMSP0BUPRENORPHINE 5NG/MLBUP 5 WB F MSPBUP 5 WB F MSP2026-08-27
B800BUS1DPFEUH0BUSULFAN LEVEL 1BUS 1 DP F EUHBUS 1 DP F EUH2026-08-26
B800BUS2DPFEUH0BUSULFAN LEVEL 2BUS 2 DP F EUHBUS 2 DP F EUH2026-08-26
B800BUS3DPFEUH0BUSULFAN LEVEL 3BUS 3 DP F EUHBUS 3 DP F EUH2026-08-26
B800BUS4DPFEUH0BUSULFAN LEVEL 4BUS 4 DP F EUHBUS 4 DP F EUH2026-08-26
B800BUS5DPFEUH0BUSULFAN LEVEL 5BUS 5 DP F EUHBUS 5 DP F EUH2026-08-26
B800BUS6DPFEUH0BUSULFAN LEVEL 6BUS 6 DP F EUHBUS 6 DP F EUH2026-08-26
B800FENTHIGHWBSCFL0FENTANYL PLUS HIGHFENT+ HIGH WB SCFLFENT+ HIGH WB SCFL2026-07-14
B800FENTLOWWBSCFL0FENTANYL PLUS LOWFENT+ LOW WB SCFLFENT+ LOW WB SCFL2026-07-14
B800LCDOAWBFMSP0DRUGS OF ABUSELCDOA WB F MSPLCDOA WB F MSP2026-07-07
B800THCCTLMFMSP0THC CONTROLTHC CTL M F MSPTHC CTL M F MSP2026-07-07
B800OPIBENZO2V4UFGML0OPI PLUS BENZO LEVEL 2 V4OPI+ BENZO 2 V4 U F GMLOPI+ BENZO 2 V4 U F GML2026-05-26
B800MORGLUC500WBFHCME0MORPHINE GLUCURONIDE 500 NG/MLMOR GLUC 500 WB F HCMEMOR GLUC 500 WB F HCME2026-04-22
B800SGULCLC0SPECIFIC GRAVITYB800SGULCLC0B800SGULCLC02026-04-22
B800DA3UFDAC0DRUGS OF ABUSE LEVEL 3DA 3 U F DACDA 3 U F DAC2026-04-16
B800FENTWBV2OCMENY0FENTANYL PLUSFENT+ WB V2 OCMENYFENT+ WB V2 OCMENY2026-04-10
B800PM100WBCMENY0PAIN 100 NG/MLPM 100 WB CMENYPM 100 WB CMENY2026-04-10
B800FENT5UFSMC0FENTANYL 5 NG/MLFENT 5 U F SMCFENT 5 U F SMC2026-04-07
B8007HMG75UFKP07-HMG 75 NG/ML7-HMG 75 U F KP7-HMG 75 U F KP2026-04-02
B800AMINCAL1BPFNHI0 AMINO ACID CAL 1 BAMIN CAL1B P F NHIAMIN CAL1B P F NHI2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B800BUP5WBFMSP0BUPRENORPHINE 5NG/MLUTAK LABORATORIES, INC.LAS2026-08-27
B800BUS1DPFEUH0BUSULFAN LEVEL 1UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS2DPFEUH0BUSULFAN LEVEL 2UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS3DPFEUH0BUSULFAN LEVEL 3UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS4DPFEUH0BUSULFAN LEVEL 4UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS5DPFEUH0BUSULFAN LEVEL 5UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS6DPFEUH0BUSULFAN LEVEL 6UTAK LABORATORIES, INC.LAS2026-08-26
B07609770LZI Fentanyl Level 1 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
B07609780LZI Fentanyl Level 2 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
B800FENTHIGHWBSCFL0FENTANYL PLUS HIGHUTAK LABORATORIES, INC.LAS2026-07-14
B800FENTLOWWBSCFL0FENTANYL PLUS LOWUTAK LABORATORIES, INC.LAS2026-07-14
B800LCDOAWBFMSP0DRUGS OF ABUSEUTAK LABORATORIES, INC.LAS2026-07-07
B800THCCTLMFMSP0THC CONTROLUTAK LABORATORIES, INC.LAS2026-07-07
B8007HMG75UFKP07-HMG 75 NG/MLUTAK LABORATORIES, INC.LAS2026-04-02
B800ACETAHIGHV2UADX0ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX0ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B80044600WBF10TCH0BLANK WHOLE BLOOD 10MLUTAK LABORATORIES, INC.LAS2025-10-29
B8006TGRQC1UK06TGR PLUS QC LEVEL 1UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC2UK06TGR PLUS QC LEVEL 2UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC3UK06TGR PLUS QC LEVEL 3UTAK LABORATORIES, INC.LAS2025-08-06
B80088121CDFASC0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2025-03-24
B80091801UAL0BUPRENORPHINE HYDROLYSIS QCUTAK LABORATORIES, INC.LAS2025-01-13
B80088121CDFL500NPM0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-12-20
B80044600WBF100MLRH0BLANK WHOLE BLOOD 100MLUTAK LABORATORIES, INC.LAS2024-12-11
B80090000UFLTI0NICOTINE PLUS LEVEL 1UTAK LABORATORIES, INC.LAS2024-09-30
B80090001UFLTI0NICOTINE PLUS LEVEL 2UTAK LABORATORIES, INC.LAS2024-09-30
B80088121CDFF10NJSP0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-09-18
B80088121CDFL50PML0CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC.LAS2024-09-05
B80011511050SMXHFAH0BLANK HAIR MATRIXUTAK LABORATORIES, INC.LAS2024-08-23
B80044600WBFPOSAFT0POSITIVE WHOLE BLOODUTAK LABORATORIES, INC.LAS2024-05-20