FDA.reportPublic FDA data

BLANK WHOLE BLOOD 50ML V2

Primary DI
B80044600WBF50V2FDLE0
Brand
BLANK WHOLE BLOOD 50ML V2
Company
UTAK LABORATORIES, INC.
Model
44600-WB(F)50 V2 FDLE
Catalog number
44600-WB(F)50 V2 FDLE
Device description
BLANK WHOLE BLOOD 50ML V2
Published
2026-11-04
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
B80044600WBF50V2FDLE0PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
B800ETOH120UFMNPD0ETHANOL 120 MG/DLETOH 120 U F MNPDETOH 120 U F MNPD2026-10-20
B800UTAKSCPREG1SFSD0PREGNENOLONE PLUS 1UTAK-SC PREG+1 S F SDUTAK-SC PREG+1 S F SD2026-10-20
B800UTAKSCPREG2SFSD0PREGNENOLONE PLUS 2UTAK-SC PREG+2 S F SDUTAK-SC PREG+2 S F SD2026-10-20
B800DAU2SUID0DAU 2 SU IDDAU 2 SU IDDRUGS OF ABUSE LEVEL 22026-10-15
B800ISACAL1V2SFUCSF0ISAVUCONAZOLE PLUS CALIBRATOR 1 V2ISA+ CAL 1 V2 S F UCSFISA+ CAL 1 V2 S F UCSF2026-10-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B800ETOH120UFMNPD0ETHANOL 120 MG/DLUTAK LABORATORIES, INC.LAS2026-10-20
B800UTAKSCPREG1SFSD0PREGNENOLONE PLUS 1UTAK LABORATORIES, INC.LAS2026-10-20
B800UTAKSCPREG2SFSD0PREGNENOLONE PLUS 2UTAK LABORATORIES, INC.LAS2026-10-20
B800DAU2SUID0DAU 2 SU IDUTAK LABORATORIES, INC.LAS2026-10-15
B800ISACAL1V2SFUCSF0ISAVUCONAZOLE PLUS CALIBRATOR 1 V2UTAK LABORATORIES, INC.LAS2026-10-07
00812101031254ARK™ Apixaban ControlARK DIAGNOSTICS INCLAS2026-09-25
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
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