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UTAK LABORATORIES, INC.

Last updated September 17, 2026

Information

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

Catalogue (1969)

Page 33 of 40

Device	Model / Reference	Registries	Class	Status
Amphetamines Level 2	AMPH 2 U KP	FDA UDI	Class I	Active
Ethanol 80mg/dL	31080	FDA UDI	Class I	Active
Lamotrigine 18 Ug/Ml	LAMO S KP	FDA UDI	Class I	Active
Certified Drug Free Urine	88121-CDF(F)100	FDA UDI	Class I	Active
Venlafaxine Plus Level 1	VEN+ 1 S IDC	FDA UDI	Class I	Active
Busulfan Level 1	BUS 1 DP UPMC	FDA UDI	Class I	Active
Arachidic Acid Level 2 V2	ARA+ 2 V2 S ID	FDA UDI	Class I	Active
Testosterone Level A	TESTO A SMX-S F UCH	FDA UDI	Class I	Active
Certified Drug Free Urine	88121-CDF(LCLIN)	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 2	ISA+ CAL 2 S F UCSF	FDA UDI	Class I	Active
Daucal5v5fsemce	DAU CAL 5 V5 F SEMCE	FDA UDI	Class I	Active
Lead Level 1	LEAD 1 V2 WB F CH	FDA UDI	Class I	Active
Immunosuppressants Level 3	IMMU 3 V2 WB F PH	FDA UDI	Class I	Active
Secobarbital Pos	POS-210-2U	FDA UDI	Class I	Active
Busulfan Calibrator 1	BUS CAL 1 P F URMC	FDA UDI	Class I	Active
Psych Panel Level 2	PSYCH 2 F M ACL	FDA UDI	Class I	Active
Drugs Of Abuse Screening Level 1	DAU 1 V2 IA QC	FDA UDI	Class I	Active
Drugs Of Abuse Calibrator 1	DAU CAL 1 U F NPIL	FDA UDI	Class I	Active
Gabapentin Level 2	GABA 2 V2 SMXU F PG	FDA UDI	Class I	Active
Nordiazepam 150 Ng/Ml	NORDIAZ 150 S M	FDA UDI	Class I	Active
Defibrinated Plasma	44600-D(500)	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA 2 S SH	FDA UDI	Class I	Active
Drugs Of Abuse	DA M F HD	FDA UDI	Class I	Active
Ethanol 200 Mg/Dl	ETH 200 WB F MSP	FDA UDI	Class I	Active
Fentanyl	FENT U F OT	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	DAU 3 V2 F U VMG	FDA UDI	Class I	Active
Drugs Of Abuse Qc Level 1 V2	DAU QC 1 V2 CCHS	FDA UDI	Class I	Active
Blank Whole Blood 100ml	44600-WB(F) 100ML RH	FDA UDI	Class I	Active
Drugs Of Abuse Negative V3	DAU NEG V3 QHS U F	FDA UDI	Class I	Active
Blank Whole Blood	BLK WB NC	FDA UDI	Class I	Active
Testosterone Level 1	TESTO 1 S F MC	FDA UDI	Class I	Active
Ethanol 80	ETH 80 U V F WVSP	FDA UDI	Class I	Active
Busulfan Level 2	BUS 2 P F EBS UK	FDA UDI	Class I	Active
Axis Vol Qc #4	ETH 350 V2 W AIT	FDA UDI	Class I	Active
Antipsych+ V3 Of F Ot	ORAL FLUID UTAK	FDA UDI	Class I	Active
Metformin Level 2	MET 2 F P EBS	FDA UDI	Class I	Active
Fentanyl Analogues 5ng/mL	10186	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 F MED	FDA UDI	Class I	Active
Voriconazole Plus Qc 1	VORI+ QC 1 SJCR	FDA UDI	Class I	Active
Drugs Of Abuse Level 4	DAU 4 F LE	FDA UDI	Class I	Active
Anabasine Plus Level 1 V2	ANAB+ 1 V2 U LC	FDA UDI	Class I	Active
Phenytoin Level 2	PHENY 2 S MCTL	FDA UDI	Class I	Active
Pmv7ufmc	PM+ V7 U F MC	FDA UDI	Class I	Active
Drugs Of Abuse 3	DA WB 3 V3 OCME	FDA UDI	Class I	Active
Fentanyl Plus Level 4	FENT+ 4 U QD	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 2	DA+2 WB V2 IMMUN	FDA UDI	Class I	Active
UTAK Urine Drug Screen	88121	FDA UDI	Class I	Active
Etg Plus Qc High	ETG+ QC HIGH U F NPIL	FDA UDI	Class I	Active
Veterinary Use Only Bromide 0.5 Mg/Ml	UTAK-SC VET BRO 0.5 S SD	FDA UDI	Class I	Active
MMA (Methylmalonic Acid) Level 1	74053	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.