FDA.reportPublic FDA data

CANNABINOIDS CALIBRATOR 2

Primary DI
B800CANNCAL2UIMMU0
Brand
CANNABINOIDS CALIBRATOR 2
Company
UTAK LABORATORIES, INC.
Model
CANN CAL 2 U IMMU
Catalog number
CANN CAL 2 U IMMU
Device description
CANNABINOIDS CALIBRATOR 2
Published
2023-03-13
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
B800CANNCAL2UIMMU0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

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
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B800AMINOACIDQC2B0AMINO ACID QC 2 BAMIN QC2B P F NHIAMIN QC2B P F NHI2026-04-01
B800AMINQC1BPFNHI0AMINO ACID QC 1 BAMIN QC1B P F NHIAMIN QC1B P F NHI2026-04-01
B800DAU2V2ID0 DRUGS OF ABUSE LEVEL 2 V2DAU 2 V2 IDDAU 2 V2 ID2026-03-03
B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2DAU 2 V2 IDDAU 2 V2 ID2026-03-03
B800DAULOWV43MLUIPM0 DRUGS OF ABUSE LOW V4DAU LOW V4 3ML U IPMDAU LOW V4 3ML U IPM2026-02-25
B800DAUHIGHV43MLUIPM0DRUGS OF ABUSE HIGH V4DAU HIGH V4 3ML U IPMDAU HIGH V4 3ML U IPM2026-02-25
B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4DAU LOW V4 3ML U IPMDAU LOW V4 3ML U IPM2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4DAU MID V4 3ML U IPMDAU MID V4 3ML U IPM2026-02-25
B800ETH177WBFOSBI0ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ETH76WBFOSBI0ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ETH177WBFOSBI5ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B800OPIBENZO2V4UFGML0OPI PLUS BENZO LEVEL 2 V4UTAK LABORATORIES, INC.LAS2026-05-26
B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-03-03
B800DAUHIGHV43MLUIPM0DRUGS OF ABUSE HIGH V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4UTAK LABORATORIES, INC.LAS2026-02-25
B800ETH177WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ETH76WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ANTIF2SQD5ANTIFUNGALS LEVEL 2UTAK LABORATORIES, INC.LAS2026-02-06
B800ANLCCALMFFCCO5 ANLC CALUTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL1V2SSH5MIXED CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL2V2SSH0MIXED CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT1V2FRX5DAU CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT2V2FRX0DAU CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACAL2V2UFRX5 EIA CAL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACALLEVEL1V25 EIA CAL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIANEGV2UFRX5 EIA NEG CAL V2UTAK LABORATORIES, INC.LAS2026-02-05
B800MET1V2WBQD5METALS LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET2V2WBQD5METALS LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET3V2WBQD5METALS LEVEL 3 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800ACETAHIGHV2UADX5ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX5ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B800MOR225UKP5MORPHINE 225 NG/MLUTAK LABORATORIES, INC.LAS2026-01-16
B800AMPH60V2WBCP5AMPH PLUS 60 NG/ML V2UTAK LABORATORIES, INC.LAS2026-01-13
B800DAUL3UFVMCI5 DRUGS OF ABUSE LEVEL 3UTAK LABORATORIES, INC.LAS2026-01-13
B800FENTUFODX5 FENTANYL PLUSUTAK LABORATORIES, INC.LAS2026-01-06
00812101031667ARK™ Ketamine II Control (25/75)ARK DIAGNOSTICS INCLAS2025-12-27
00812101031674ARK™ Ketamine II Control (75/125)ARK DIAGNOSTICS INCLAS2025-12-27
B800AMPQC1URIH5AMPHETAMINE LEVEL 1UTAK LABORATORIES, INC.LAS2025-12-15
B800AMPQC2URIH5AMPHETAMINE LEVEL 2UTAK LABORATORIES, INC.LAS2025-12-15
B800TRAM400UDEAW5TRAMADOL 400 NG/MLUTAK LABORATORIES, INC.LAS2025-09-26