FDA.reportPublic FDA data

TOTAL PSA 400 NG/ML

Primary DI
B800PSA400SFBD5
Brand
TOTAL PSA 400 NG/ML
Company
UTAK LABORATORIES, INC.
Model
PSA 400 S F BD
Catalog number
PSA 400 S F BD
Device description
TOTAL PSA 400 NG/ML
Published
2024-01-26
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

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
B800PSA400SFBD5PackageHIBCC5In Commercial Distribution
B800PSA400SFBD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 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
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

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