FDA.reportPublic FDA data

OPIATES 500 NG/ML

Primary DI
B80004830000010
Brand
OPIATES 500 NG/ML
Company
UTAK LABORATORIES, INC.
Model
OPIA 500 U
Published
2022-04-25
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
B80004830000011PackageHIBCC4In Commercial Distribution
B80004830000012PackageHIBCC5In Commercial Distribution
B80004830000013PackageHIBCC10In Commercial Distribution
B80004830000016PackageHIBCC25In Commercial Distribution
B80004830000017PackageHIBCC50In Commercial Distribution
B80004830000018PackageHIBCC100In Commercial Distribution
B80004830000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite 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 opiate and/or opiate metabolites in a clinical specimen.

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

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
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
B800AED1V3SHCMC0AED LEVEL 1 V3UTAK LABORATORIES, INC.LAS2025-08-25
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
B800AEDSSCH0AED PLUSUTAK LABORATORIES, INC.LAS2024-07-17
B80044600WBFPOSAFT0POSITIVE WHOLE BLOODUTAK LABORATORIES, INC.LAS2024-05-20
B80088121CDFF10FS0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-05-06
B8007AMINOHIGHUPM07-AMINOCLONAZEPAM HIGHUTAK LABORATORIES, INC.LAS2024-05-03
B8007AMINOLOWUPM07-AMINOCLONAZEPAM LOWUTAK LABORATORIES, INC.LAS2024-05-03
B80088121CDFF100PDH0CERTIFIED DRUG FREE URINE 100MLUTAK LABORATORIES, INC.LAS2024-04-30
B80066815V3HRLC0HIGH RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B80066816V3NRLC0NORMAL RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B800ACETAUV4PM0ACETAMINOPHEN PLUS V4UTAK LABORATORIES, INC.LAS2024-03-12
B80092021IDC0SSRI 12 LEVEL 2UTAK LABORATORIES, INC.LAS2024-03-06
B800ACE250SFBSRHS0ACETONE 250 MG/DLUTAK LABORATORIES, INC.LAS2024-02-27
B80088121CDFLLTRWVDTL0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-02-20
B800ACIDNEUTQC0ACID-NEUT QCUTAK LABORATORIES, INC.LAS2024-02-16