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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 32 of 40

Device	Model / Reference	Registries	Class	Status
Nicotine Plus 100 Ng/Ml V3	NICO+ 100 V3 U F UWHC	FDA UDI	Class I	Active
Benzodiazepines Level 1 V2	BENZO L1 V2 U F UW	FDA UDI	Class I	Active
Busulfan Cal 4000 Ng/Ml	BUS CAL 4000 UCSF	FDA UDI	Class I	Active
Lamotrigine Plus Level 2	LAMO+ 2 S UPENN	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	SMX-DAU 2 V2 F PG	FDA UDI	Class I	Active
Immunoassay Level 2	IMMUNO 2 V2 ARUP	FDA UDI	Class I	Active
Urine Broad Panel Low	UBP L F DU	FDA UDI	Class I	Active
Drugs Of Abuse Screening Level 1	DAU 1 V3 IA QC	FDA UDI	Class I	Active
Mma 200 Nmol/L	MMA 200 F QD	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 1	ISA+ CAL 1 S F UCSF	FDA UDI	Class I	Active
Acid Plus	ACID+ M TCME	FDA UDI	Class I	Active
Methotrexate Level 3	METHO 3 S QD	FDA UDI	Class I	Active
Pentobarbital 12 Ug/Ml	PENTO 12 JHH	FDA UDI	Class I	Active
Cystathionine Plus Level 5	CYST+ 5 LC	FDA UDI	Class I	Active
Venlafaxine Plus Level 3	VEN+ 3 S IDC	FDA UDI	Class I	Active
7-Hydroxymitragynine Qc High V5	HMITR U QC H V5 SEMCE	FDA UDI	Class I	Active
Ethanol Tri-Level Set	ETH SET WB LC	FDA UDI	Class I	Active
Drugs Of Abuse -50%	DAU SCR -50 SAFE	FDA UDI	Class I	Active
Phencyclidine Plus	PCP+ U MAYO	FDA UDI	Class I	Active
Thc Pos	POS-205-2U	FDA UDI	Class I	Active
Immunosuppressants Level 2	IMMUN 2 WB F UNC	FDA UDI	Class I	Active
Pain Management 100 Ng/Ml	PM 100 V3 U F KP	FDA UDI	Class I	Active
Benzodiazepines Plus	QC-A SCC	FDA UDI	Class I	Active
Drugs Of Abuse Qc Mid	DAU QC MID F NPIL	FDA UDI	Class I	Active
Lead Level 1	LEAD 1 V2 WB V WDL	FDA UDI	Class I	Active
Axis Vol Qc#2	AXIS VOL QC#2	FDA UDI	Class I	Active
Magnesium Low	MAGN L RBC F CHANT	FDA UDI	Class I	Active
Immunosuppressants Level 2	IMMUNOS 2 WB F ARUP	FDA UDI	Class I	Active
Ghb 25 Ug/M	GHB 25 U NJSP	FDA UDI	Class I	Active
Eia Standard V3	EIA STD V3 WB DOJ	FDA UDI	Class I	Active
Benzodiazepines Hydrolysis Qc	91800	FDA UDI	Class I	Active
Dau Qc High V4	DAU QC H V4 SEMCE	FDA UDI	Class I	Active
Tca 200 Ng/Ml	TCA 200 V2 S LHS	FDA UDI	Class I	Active
Lead Level 1	LEAD 1 WB F UCI	FDA UDI	Class I	Active
Calibrator C	CAL C U F SD	FDA UDI	Class I	Active
Ketamine Pos	POS-240-2U	FDA UDI	Class I	Active
Calibrator B	CAL B U F SD	FDA UDI	Class I	Active
Tcme Miscellaneous	MISC M TCME	FDA UDI	Class I	Active
Etg Plus Level 2	ETG+ 2 V2 U F CCL	FDA UDI	Class I	Active
Fentanyl Plus Level 1	FENT+ 1 S F MAYO	FDA UDI	Class I	Active
Amphetamine Pos	POS-209-2U	FDA UDI	Class I	Active
Opiates Level 3	OPIA 3 U UNC	FDA UDI	Class I	Active
Anabasine Plus Level 1	ANAB+ 1 U LC	FDA UDI	Class I	Active
Kit Dau	DAU N F V POTM	FDA UDI	Class I	Active
Methotrexate Plus 1	METHO+ 1 S F MSKCC	FDA UDI	Class I	Active
Drugs Of Abuse Qc Low	DAU QC LOW F NPIL	FDA UDI	Class I	Active
Gabapentin Level 1 V2	GABA 1 V2 SMXU F PG	FDA UDI	Class I	Active
Voriconazole Plus Cal 4	VORI+ CAL 5 SJCR	FDA UDI	Class I	Active
Nicotine Plus Level 3	NIC+ 3 U F UHCMC	FDA UDI	Class I	Active
Busulfan Level 3	BUS C3 MAYO	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.