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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 22 of 40

Device	Model / Reference	Registries	Class	Status
Blank Whole Blood	44600-WB(F)950	FDA UDI	Class I	Active
Drugs Of Abuse Cal Level 1	DAU+ L LEVEL 1 V2 URMC	FDA UDI	Class I	Active
Positive Plasma	POS P F MSKCC	FDA UDI	Class I	Active
Dau Level 1	DAU 1 DTPM	FDA UDI	Class I	Active
Leflunomide V2 Low Level 3	LEFLU V2 L L3	FDA UDI	Class I	Active
Volatiles Plus Low	VOL+ H MCV	FDA UDI	Class I	Active
Opiates High	OPIA H S LC	FDA UDI	Class I	Active
SMx CEREBRAL SPINAL FLUID	SMX-CSF F MAYO	FDA UDI	Class I	Active
Dau Negative V2	DAU NEG F V2 UVHS	FDA UDI	Class I	Active
Ethanol 80	ETH 80 WB V F WVSP	FDA UDI	Class I	Active
Drugs Of Abuse Mid V2	DAU MID V2 F PG	FDA UDI	Class I	Active
Antifungal Qc Level 1	ANTIF QC 1 V2 LP F TF	FDA UDI	Class I	Active
Flu2ufaht	FLU+ 2 U F AHT	FDA UDI	Class I	Active
Methamphetamine Pos	POS-211-2U	FDA UDI	Class I	Active
Thc Level 2	THC U 2 F PG	FDA UDI	Class I	Active
Antifungals Level 1	ANTIF 1 S UPHS	FDA UDI	Class I	Active
Etg Qc Plus	ETG QC M LB	FDA UDI	Class I	Active
Drugs Of Abuse Level 4	DAU 4 NJSP	FDA UDI	Class I	Active
Ethanol 250 Mg/Dl	ETH 250 WB F UM	FDA UDI	Class I	Active
Spirits Level 2	SPIRITS 2 WB F OCMEO	FDA UDI	Class I	Active
Alpt23 Etoh 06	ALPT23_ETOH 06	FDA UDI	Class I	Active
7-Aminoclonazepam Low	7-AMINO LOW UPM	FDA UDI	Class I	Active
Testosterone Level 2	TESTO 2 S F MC	FDA UDI	Class I	Active
Benzodiazepines Plus 100ng	12100	FDA UDI	Class I	Active
Benzodiazepines +25%	BENZO +25 PM	FDA UDI	Class I	Active
Opiates Level 1	OPI 1 U F VAMCI	FDA UDI	Class I	Active
Infliximab Level 1	INFLIX QC 1 UPHS	FDA UDI	Class I	Active
Drugs Of Abuse Screening Level 2	DAU 2 V3 IA QC	FDA UDI	Class I	Active
Opiates Calibrator Level 1	OPI U CAL 1 UNC	FDA UDI	Class I	Active
Testosterone 600 Ng/Dl	TESTO 600 S KPRICH	FDA UDI	Class I	Active
Metformin Level 1	MET 1 F P EBS	FDA UDI	Class I	Active
Vitamin D Plus Level 1	VIT D+ 1 S KPRICH	FDA UDI	Class I	Active
Tox I_02 24	TOX I_02 24	FDA UDI	Class I	Active
Certified Drug Free Urine	CDF U 1L SMA	FDA UDI	Class I	Active
Ethanol 100 Mg/Dl	ETH 100 S CRL	FDA UDI	Class I	Active
Etg Plus Calibrator 4	ETG+ CAL 4 U F NPIL	FDA UDI	Class I	Active
Drugs Of Abuse Cutoff	DA CUT V2 S F PL	FDA UDI	Class I	Active
Spirits Level 3	SPIRITS 3 U F OCMEO	FDA UDI	Class I	Active
Arsenic Plus Level 3	ARSEN+ 3 V2 U F LC	FDA UDI	Class I	Active
Dau Calibrator Level 1	DAU CAL 1 V4 F SEMCE	FDA UDI	Class I	Active
Validity Control Level 2	VAL 2 SH	FDA UDI	Class I	Active
Tof Low	TOF LOW WB PM	FDA UDI	Class I	Active
Vitamin D	VIT D S EBS UK	FDA UDI	Class I	Active
Hr Metals	MET HR U QD	FDA UDI	Class I	Active
Testosterone Plus Level 1	TESTO+ 1 WB MTL	FDA UDI	Class I	Active
Drugs Of Abuse Low	DAU L V2 F UPHS	FDA UDI	Class I	Active
Voriconazole Plus 1	VOR+ 1 V2 S F UNC	FDA UDI	Class I	Active
Nicotine Plus Level 1	NIC+ 1 U F UHCMC	FDA UDI	Class I	Active
Benzodiazepines Plus	BENZO+ U F TRL	FDA UDI	Class I	Active
Trace Elements Qc Level 3	TRACE QC 3 S PAML	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.