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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
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FDA FEI Number
2022375
DUNS Number
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Catalogue (1969)

Page 29 of 40
DeviceModel / ReferenceRegistriesClassStatus
Dau Thc Level 1 DAU THC 1 F OL
FDA UDI
Class IActive
Voriconazole Plus Cal 6 VORI+ CAL 6 SJCR
FDA UDI
Class IActive
Blank Whole Blood 100 Ml 44600-WB(F) 100
FDA UDI
Class IActive
Spirits Level 1 SPIRITS 1 S F OCMEO
FDA UDI
Class IActive
Buprenorphine Glucuronide V2 BUP GLUC+ QC V2 U F HCMC
FDA UDI
Class IActive
Thc Level 3 THC 3 U F WDH
FDA UDI
Class IActive
Volatiles VOL SMX-VH F OCMEO
FDA UDI
Class IActive
Ethanol 150 ETH 150 S V F WVSP
FDA UDI
Class IActive
Dexamethasone Level 1 DEXA 1 S F PM
FDA UDI
Class IActive
Testosterone Level C TESTO C SMX-S F UCH
FDA UDI
Class IActive
Rt3 Level 2 RT3 2 S F PG
FDA UDI
Class IActive
Drugs Of Abuse DAU F LAB2
FDA UDI
Class IActive
Certified Drug Free Urine CDF L LTR DSHS
FDA UDI
Class IActive
Lead Level 3 LEAD 3 WB F BCH
FDA UDI
Class IActive
Drugs Of Abuse DA M F PL V2
FDA UDI
Class IActive
Drugs Of Abuse Positive DAU POS V2 U F PHHC
FDA UDI
Class IActive
Ethylene Glycol Level 2 ETHGLY 2 V2 S F RIH
FDA UDI
Class IActive
Ethanol 120 Mg/Dl ETH 120 U TCRFL
FDA UDI
Class IActive
Thc 1500 Ng/Ml THC 1500 U PM
FDA UDI
Class IActive
Drugs Of Abuse DAU F ISPP
FDA UDI
Class IActive
Peth Level 3 V2 PETH 3 V2 WB F HFHS
FDA UDI
Class IActive
Pentobarbital PENTO S SCVHH
FDA UDI
Class IActive
Dextromethorphan Plus UTAK-UC DEX+ SD
FDA UDI
Class IActive
Carbamazepine-10, 11-Epoxide Level 1 C1011 L1 V4
FDA UDI
Class IActive
Dau Positive DAU POS F TQHS
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DAU 1 F SD
FDA UDI
Class IActive
Metals High METALS HIGH S F EBS
FDA UDI
Class IActive
Benzodiazepines Level 1 BENZO L1 U F UW
FDA UDI
Class IActive
Drugs Of Abuse Qc Level 1 DA SMX-OF QC 1
FDA UDI
Class IActive
Amines High AMINES H V2 CONT
FDA UDI
Class IActive
Of Qc 3 QC 3 SMX-OF
FDA UDI
Class IActive
Drugs Of Abuse Level 1 V2 DAU QC 1 V2 F NHI
FDA UDI
Class IActive
Daumidv4f2pttl DAU MID V4 F 2PT TL
FDA UDI
Class IActive
Barbiturates Plus Calibrator BARB+ CAL M F ACL
FDA UDI
Class IActive
Magnesium High MAGN H RBC F CHANT
FDA UDI
Class IActive
Amitriptyline Plus Level 1 AMIT+ 1 U F V2 TRL
FDA UDI
Class IActive
Opiates Calibrator Level 2 OPI U CAL 2 UNC
FDA UDI
Class IActive
Gabapentin Level 2 GABA 2 SMXU F PG
FDA UDI
Class IActive
Vitamin A Plus High VIT A+ HIGH PM
FDA UDI
Class IActive
Defibrinated Plasma DP 5 V2 OVMC
FDA UDI
Class IActive
Da Set 1 Positive DA 1 POS WB NC
FDA UDI
Class IActive
Dauqcmv5semce DAU QC M V5 SEMCE
FDA UDI
Class IActive
Carbamazepine-10, 11-Epoxide Level 3 C1011 L3 V3
FDA UDI
Class IActive
Fentanyl Plus Level 1 FENT+ 1 V2 U NJSP
FDA UDI
Class IActive
Serum Drug Screen Level 1 DS 1 S ID
FDA UDI
Class IActive
Immunosuppressants Level 2 IMMU 2 WB KPNH
FDA UDI
Class IActive
Immunosuppressants Level 3 IMMUNO 3 F WB UW
FDA UDI
Class IActive
Methamphetamine Cal Set POS-M220-2-3
FDA UDI
Class IActive
Drugs Of Abuse Level 1 SMX-DAU 1 F PG
FDA UDI
Class IActive
Ph 4.6 PH 4.6 U PACTOX
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.