FDA.reportPublic FDA data

DAUCAL3V5FSEMCE

Primary DI
B800DAUCAL3V5FSEMCE0
Brand
DAUCAL3V5FSEMCE
Company
UTAK LABORATORIES, INC.
Model
DAU CAL 3 V5 F SEMCE
Catalog number
DAU CAL 3 V5 F SEMCE
Device description
DAUCAL3V5FSEMCE
Published
2023-06-07
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

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
B800DAUCAL3V5FSEMCE0PrimaryHIBCC0

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 Volume2Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2DAU 2 V2 IDDAU 2 V2 ID2026-03-03
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
B800ETH177WBFOSBI5ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ETH76WBFOSBI5ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ANTIF2SQD5ANTIFUNGALS LEVEL 2ANTIF 2 S QDANTIF 2 S QD2026-02-06
B800ANLCCALMFFCCO5 ANLC CALANLC CAL M F FCCOANLC CAL M F FCCO2026-02-05
B800CONTROL1V2SSH5MIXED CONTROL LEVEL 1 V2CONTROL 1 V2 S SHCONTROL 1 V2 S SH2026-02-05
B800CONTROL2V2SSH0MIXED CONTROL LEVEL 2 V2CONTROL 2 V2 S SHCONTROL 2 V2 S SH2026-02-05
B800DAUCONT1V2FRX5DAU CONTROL LEVEL 1 V2DAU CONT 1 V2 F RXDAU CONT 1 V2 F RX2026-02-05
B800DAUCONT2V2FRX0DAU CONTROL LEVEL 2 V2DAU CONT 2 V2 F RXDAU CONT 2 V2 F RX2026-02-05
B800EIACAL2V2UFRX5 EIA CAL LEVEL 2 V2EIA CAL 2 V2 U F RXEIA CAL 2 V2 U F RX2026-02-05
B800EIACALLEVEL1V25 EIA CAL LEVEL 1 V2EIA CAL 1 V2 U F RXEIA CAL 1 V2 U F RX2026-02-05
B800EIANEGV2UFRX5 EIA NEG CAL V2EIA NEG V2 U F RXEIA NEG V2 U F RX2026-02-05
B800MET1V2WBQD5METALS LEVEL 1 V2MET 1 V2 WB QDMET 1 V2 WB QD2026-02-02
B800MET2V2WBQD5METALS LEVEL 2 V2MET 2 V2 WB QDMET 2 V2 WB QD2026-02-02
B800MET3V2WBQD5METALS LEVEL 3 V2MET 3 V2 WB QDMET 3 V2 WB QD2026-02-02
B800ACETAHIGHV2UADX5ACETAMINOPHEN PLUS HIGH V2ACETA+ HIGH V2 U ADXACETA+ HIGH V2 U ADX2026-01-16

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