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UTAK LABORATORIES, INC.

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: —

Catalogue (1969)

Page 7 of 40

Device	Model / Reference	Registries	Class	Status
Aldosterone Level 3	ALDO 3 F UVHS	FDA UDI	Class I	Active
Chloride Plus Conductivity 3	CHL+ C 3	FDA UDI	Class I	Active
Calibrator D	CAL D U F SD	FDA UDI	Class I	Active
Fentanyl Analogues 2ng/mL	10189	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 3 V2	ISA+ CAL 3 V2 S F UCSF	FDA UDI	Class I	Active
Fentanyl Plus Level 2	FENT+ 2 QD	FDA UDI	Class I	Active
Etg Plus Qc Level 2 V2	ETG+ QC 2 V2 U F UCSF	FDA UDI	Class I	Active
Blank Hair Matrix	115110(50) SMXH F AH	FDA UDI	Class I	Active
Validity Check Hr	VAL HR U UK	FDA UDI	Class I	Active
Edta Smx Whole Blood	EDTA SMX-WB F MC	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 4	DA+ 1 WB IMMUN	FDA UDI	Class I	Active
Vitamin D Plus Level 2	10062	FDA UDI	Class I	Active
Urine Qc Low V4	U QC LOW V4 EL	FDA UDI	Class I	Active
Vitamin B6 200 Ng/Ml	VIT B6 S F	FDA UDI	Class I	Active
Drugs Of Abuse Negative Screen	DAU NEG U F PHHC	FDA UDI	Class I	Active
Phencyclidine 1 Ug/Ml	PCP 1 U KPRICH	FDA UDI	Class I	Active
Thc Level 3	THC U 3 F PG	FDA UDI	Class I	Active
Psych Urine V5 Calibrator	PSY UR V5 CAL	FDA UDI	Class I	Active
Ethanol 25 Mg/Dl	ETH 25 U 2PT ML	FDA UDI	Class I	Active
Phenytoin Level 3	PHENY 3 S MCTL	FDA UDI	Class I	Active
Drugs Of Abuse Level 2 V3	DAU 2 V3 F VMG	FDA UDI	Class I	Active
Blank Whole Blood	44600-WB(F)50	FDA UDI	Class I	Active
Elisa High Positive Control	ELISA HPC WB OSBI	FDA UDI	Class I	Active
Dau B Level 2 V2	DAU B 2 V2 F IHL	FDA UDI	Class I	Active
Opiates Calibrator 1	OPIA CAL 1 U IMMU	FDA UDI	Class I	Active
Thioc 18 Uw	THIOCYANATE 18 MG/DL	FDA UDI	Class I	Active
Thc Plus Level 7	THC+ 7 U F WCT	FDA UDI	Class I	Active
Butalbital Plus 3 V2	BUTALBITAL+ 3 V2 AP	FDA UDI	Class I	Active
Kit Dau V3	KIT DAU V3 POTM	FDA UDI	Class I	Active
Dauposfuvhs	DAU POS F UVHS	FDA UDI	Class I	Active
Amphetamines Panel Level 1	41400	FDA UDI	Class I	Active
Qlod-Wb Level 2	QLOD-WB 2 NTL	FDA UDI	Class I	Active
Nicotine Plus Level 2	NICO+ 2 F QC LC	FDA UDI	Class I	Active
Mid Range AED II	72741	FDA UDI	Class I	Active
Drugs Of Abuse Level 3 V3	DAU 3 V3 F VMG	FDA UDI	Class I	Active
Drugs Of Abuse Positive	DA POS V2 WB F KBI	FDA UDI	Class I	Active
Drugs of Abuse 505 Cutoff Oral Fluid	43050	FDA UDI	Class I	Active
Drugs Of Abuse Low	DAU L V2 F MAYO	FDA UDI	Class I	Active
Dau Ia 1	50600	FDA UDI	Class I	Active
Tox I_05 24	TOX I_05 24	FDA UDI	Class I	Active
Methamphetamines Calibrator 3	METH CAL 3 U IMMU	FDA UDI	Class I	Active
Tox Ii_07 24	TOX II_07 24	FDA UDI	Class I	Active
Tricyclics Level 2 V2	TCA L2 V2 S MAYO	FDA UDI	Class I	Active
Volatiles Level 1	VOL 1 V2 S MAYO	FDA UDI	Class I	Active
Hmsb Level 1	HMSB 1 WB F MAYO	FDA UDI	Class I	Active
Immunosuppressants Level 4	IMMU 4 WB WDL	FDA UDI	Class I	Active
Metals Level 1	MET 1 WB QD	FDA UDI	Class I	Active
Drugs Of Abuse Cal Level 2	DAU+ L LEVEL 2 V2 URMC	FDA UDI	Class I	Active
Tricyclics Level 2 V4	TCA L2 V4 S MAYO	FDA UDI	Class I	Active
Amphetamines Panel Level 2	AMPH 2 U F UW	FDA UDI	Class I	Active

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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.

Date	Recall No.	Class	Status	Reason
Mar 20, 2020	Z-2407-2020	—	terminated	The product has an incorrect reference value for cadmium and an incorrect expected range.