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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 25 of 40

Device	Model / Reference	Registries	Class	Status
Thc 1500 Ng/Ml	THC 1500 U ADX	FDA UDI	Class I	Active
Serum Drug Screen Level 5	DS 5 S ID	FDA UDI	Class I	Active
Psych Urine V3 Calibrator	PSY UR V3 CAL	FDA UDI	Class I	Active
Alprazolam Plus 2	ALP+ 2 V2 S SH	FDA UDI	Class I	Active
Volatiles Qc Level 2	VOL QC 2 V2 U 2-PT LSA	FDA UDI	Class I	Active
Butalbital Plus 1 V2	BUTALBITAL+ 1 V2 AP	FDA UDI	Class I	Active
Antifungals Level 3	A-FUNG L3 S F UW	FDA UDI	Class I	Active
Cannabinoids Cal Set	POS-M145-2-3	FDA UDI	Class I	Active
Antifungals Level 1	A-FUNG L1 S F MAYO	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 F OL	FDA UDI	Class I	Active
Immunosuppressants Level 2	IMMU 2 WB WD	FDA UDI	Class I	Active
Drugs Of Abuse	DAU V F SCCCL	FDA UDI	Class I	Active
Testosterone Level E	TESTO E SMX-S F UCH	FDA UDI	Class I	Active
Cortisol 7000 Nmol/L	CORT 7000 S F BD	FDA UDI	Class I	Active
Amphetamine Cutoff	AMPH CUT S NC	FDA UDI	Class I	Active
Peth Level 2	PETH 2 K2WB F UM	FDA UDI	Class I	Active
Metals Level 3	MET 3 WB MAYO	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU QC 2 F MED	FDA UDI	Class I	Active
Fentanyl Calibrator Level 5	FENT+ CAL 5 U F KP	FDA UDI	Class I	Active
Volatiles 150 Mg/Dl	VOL 150 MMC	FDA UDI	Class I	Active
Leflunomide High Level 2	LEFLU HIGH L2 V2	FDA UDI	Class I	Active
Da Set 1 Cutoff	DA 1 CUT S NC	FDA UDI	Class I	Active
Volatiles 0.1 G/Dl	VOL WB V2 F FCL	FDA UDI	Class I	Active
Cotinine Level 3	COT 3 PM NT	FDA UDI	Class I	Active
7-Hydroxymitragynine Qc Low V5	HMITR U QC L V5 SEMCE	FDA UDI	Class I	Active
Dau Low	DAU L F TQHS	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 CRPM	FDA UDI	Class I	Active
Busulfan Calibrator Level 2 V2	BUS CAL 2 V2 DP F MDACC	FDA UDI	Class I	Active
Meperidine Plus Level 3	MEP+ 3 S LC	FDA UDI	Class I	Active
Fentanyl Plus Level 1	FENT+ 1 U F MAYO	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 V2 F U VMG	FDA UDI	Class I	Active
Immunosuppressants Level 3	41632	FDA UDI	Class I	Active
Immunosuppressants Level 2	41631	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA 2 V2 WB NJSP	FDA UDI	Class I	Active
Drugs Of Abuse Mid 3ml	DAU MID V3 3ML U IPM	FDA UDI	Class I	Active
Normal Range Trace Elements V3	66816 V3 NR LC	FDA UDI	Class I	Active
Drugs Of Abuse Qc Level 2	DA SMX-OF QC 2	FDA UDI	Class I	Active
Lead Level 4 V4	EAD 4 V4 WB F CH	FDA UDI	Class I	Active
Amphetamine Plus 375 Ng/Ml V3	AMPH+ 375 V3 UCSF	FDA UDI	Class I	Active
Bismuth 30 Ug/L	BIS 30 U QD	FDA UDI	Class I	Active
Alprazolam Plus 1	ALP+ 1 V2 S SH	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 4	DA+4 WB V2 IMMUN	FDA UDI	Class I	Active
Lead Level 3	LEAD 3 WB F UCI	FDA UDI	Class I	Active
Drugs Of Abuse Calibrator	DOA CAL M F ACL	FDA UDI	Class I	Active
Barbiturates Plus Mid	BARBS+ M S F LC	FDA UDI	Class I	Active
Oral Fluid Utak	ANTIPSYCH+ V4 OF F OT	FDA UDI	Class I	Active
Pt Sample 2019 V2	PT 2019 UTAK V2	FDA UDI	Class I	Active
Busulfan Calibrator 4	BUS CAL 4 P F URMC	FDA UDI	Class I	Active
Clozapine 250 Ng/Ml V2	CLOZ 250 V2 UCI	FDA UDI	Class I	Active
Dihydrocodeine Level 2	DHC 2 WB UK	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.