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UTAK LABORATORIES, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
25020 AVENUE TIBBITTS, VALENCIA, CA, 91355
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2022375
DUNS Number
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Catalogue (1969)

Page 30 of 40
DeviceModel / ReferenceRegistriesClassStatus
Immunosuppressants Qc 3 025090-0003
FDA UDI
Class IActive
Benzodiazepines Low BENZO L U F NDRH
FDA UDI
Class IActive
Serum Drugs Level 2 V2 DRUGS 2 V2 S SH
FDA UDI
Class IActive
Steroids Mid STER M S F SHC
FDA UDI
Class IActive
Metals Mid MET MID WB F IL
FDA UDI
Class IActive
Drugs Of Abuse High DAU HIGH F PG
FDA UDI
Class IActive
Methylmalonic Acid 10 Umol/L MMA 10 S F KPRICH
FDA UDI
Class IActive
Opiates Plus Benzo Level 2 OPI+ BENZO 2 U F GML
FDA UDI
Class IActive
Ethanol Level 2 ETH 2 WB F UDH
FDA UDI
Class IActive
Quality Control 3 QC 3 U F OSUMC
FDA UDI
Class IActive
Dau Level 1 DAU 1 F V2 UTMB
FDA UDI
Class IActive
Methamphetamine Plus METH+ P UCD
FDA UDI
Class IActive
Bus 900 Dp Mskcc BUS 900 DP MSKCC
FDA UDI
Class IActive
Validity Check Lr VAL LR U UK
FDA UDI
Class IActive
Tricyclics Level 2 TRIC 2 QDCHANT V2
FDA UDI
Class IActive
Methanol Plus 2 METH+ 2 UCD
FDA UDI
Class IActive
Voriconazole Plus 2 VOR+ 2 V2 S F UNC
FDA UDI
Class IActive
Dau Low DAU LOW ABS
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DA 1 V2 F WB TDHS
FDA UDI
Class IActive
Thc Plus Level 1 THC+ 1 WB 2PT F SDHL
FDA UDI
Class IActive
Opiates Calibrator 2 OPIA CAL 2 U IMMU
FDA UDI
Class IActive
Thc Plus Level 2 THC+ 2 V WB F EPCCO
FDA UDI
Class IActive
Pregnenolone Plus REGN+ SMX S F PC
FDA UDI
Class IActive
Drugs Of Abuse Qc 1 DAU QC 1 V2 F BILH
FDA UDI
Class IActive
High Range Trace Elements V3 66815 V3 HR LC
FDA UDI
Class IActive
Benzoylecgonine 700 Ng/Ml BENZOY 700 U F APS
FDA UDI
Class IActive
Veterinary Use Only Bromide 1.2 Mg/Ml UTAK-SC VET BRO 1.2 S SD
FDA UDI
Class IActive
Gabapentin Level 3 V2 GABA 3 V2 SMXU F PG
FDA UDI
Class IActive
Codeine Gluc Plus Level 1 COD GLUC+ 1 U F YNHH
FDA UDI
Class IActive
Benzoylecgonine Control 2 BE+ CONT 2 U
FDA UDI
Class IActive
Md Labs 23 Level 2 V4 MD LABS 23 2 V4 OF
FDA UDI
Class IActive
Nifedipine Plus NIF+ S F EBS
FDA UDI
Class IActive
Drugs Of Abuse Qc 3 DAU QC 3 F BILH
FDA UDI
Class IActive
Blank Whole Blood 50ml 44600-WB(F)50 FDLE
FDA UDI
Class IActive
Meperidine Plus Level 1 MEP+ 1 S LC
FDA UDI
Class IActive
Hydroxyprogesterone Level 1 HPROG 1 S F FUMC
FDA UDI
Class IActive
Etg Plus Calibrator Level 2 ETG+ CAL 2 V2 U F UCSF
FDA UDI
Class IActive
Tepa Plus Level 2 V2 TEPA+ 2 V2 DP F MSKCC
FDA UDI
Class IActive
Cys1uslp CYS 1 U SLP
FDA UDI
Class IActive
Iodine Qc Level 1 IOD QC 1 U QDVA
FDA UDI
Class IActive
Thc Level 5 THC 5 U F WDH
FDA UDI
Class IActive
Spirits Level 3 SPIRITS 3 SMX-VH F OCMEO
FDA UDI
Class IActive
Certified Drug Free Urine CDF+SF U F DOJ
FDA UDI
Class IActive
Benzodiazepines High BENZO H U F NDRH
FDA UDI
Class IActive
Delta-9-Thc 8 Ng/Ml DELTA 9 OMEGA
FDA UDI
Class IActive
Fentanyl Plus Level 2 FENT+ 2 U F MAYO
FDA UDI
Class IActive
Benzodiazepines Qc Level 2 BENZO QC2 U ADX
FDA UDI
Class IActive
Benzodiazepines Calibrator 2 BENZO CAL 2 U IMMU
FDA UDI
Class IActive
Ccss Control CCSS M F TL
FDA UDI
Class IActive
High Range Urine Metals 12110
FDA UDI
Class IActive

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 20, 2020Z-2407-2020—terminated

The product has an incorrect reference value for cadmium and an incorrect expected range.