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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 8 of 40

Device	Model / Reference	Registries	Class	Status
Voriconazole Plus Level 1	VORI+ 1 V2 S CMCD	FDA UDI	Class I	Active
Chromium Plus Level 1	CHROM+ 1 WB QD	FDA UDI	Class I	Active
Stock 4	STK 4 WB V2 BD 22	FDA UDI	Class I	Active
Etoh Ii_06 24	ETOH II_06 24	FDA UDI	Class I	Active
Antifungals Calibrator 3	ANTI 3 S F UNC	FDA UDI	Class I	Active
Metals Level 2	MET 2 WB MAYO	FDA UDI	Class I	Active
Vitamin D 140 Ng/Ml	VIT D 140 S ALV	FDA UDI	Class I	Active
Dau Qc Kit	DAU QC KIT ABS	FDA UDI	Class I	Active
Hmsb Level 3 V2	HMSB 3 V2 WB F MAYO	FDA UDI	Class I	Active
Immunoassay Level 3	IMMUNO 3 V2 ARUP	FDA UDI	Class I	Active
Serum Drug Screen Level 3	DS 3 S ID	FDA UDI	Class I	Active
Acetaminophen Plus 2	ACETA+ V3 2 S F BD	FDA UDI	Class I	Active
Defibrinated Plasma	DP 10 F LAC/USC	FDA UDI	Class I	Active
Drugs Of Abuse Screen Positive	DAU POS F QC VU	FDA UDI	Class I	Active
Drugs Of Abuse Qc High	DA QC HIGH U F UMHC	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 V2 SAPC	FDA UDI	Class I	Active
Pentobarbital Level 1	PENTO 1 V2 S BH	FDA UDI	Class I	Active
Savuconazole Plus Calibrator 5	ISA+ CAL 5 S F UCSF	FDA UDI	Class I	Active
Drugs Of Abuse A Level 2	DAU A 2 F BCPC	FDA UDI	Class I	Active
Cannabinoids Calibrator 4	CANN CAL 4 U IMMU	FDA UDI	Class I	Active
Drugs Of Abuse Low	DAU L NIH	FDA UDI	Class I	Active
Dau 2 V3 Ucsd	DAU LEVEL 2 V3	FDA UDI	Class I	Active
Psych Panel Level 1	PSYCH 1 F M ACL	FDA UDI	Class I	Active
Infliximab Level 2	INFLIX QC 2 UPHS	FDA UDI	Class I	Active
Certified Drug Free Urine	CDF U F 400 CL	FDA UDI	Class I	Active
Lead 30 Ug/Dl	LEAD 30 F WB NEPM	FDA UDI	Class I	Active
Amiodarone Plus 3 Ug/Ml	AMIO+ 3 MAYO	FDA UDI	Class I	Active
Ethanol 100 Mg/Dl	ETH 100 WB F CCH	FDA UDI	Class I	Active
Dau Qc Mid V4	DAU QC M V4 SEMCE	FDA UDI	Class I	Active
6-Monoacetylmorphine Level 3	6-MAM 3 OF NAVIS	FDA UDI	Class I	Active
Fentanyl Calibrator Level 1	FENT+ CAL 1 U F KP	FDA UDI	Class I	Active
Methamphetamine 500 Ng/Ml	POS-M220-3-2ML	FDA UDI	Class I	Active
Carisoprodol Plus	CARIS+ OF F LAB24	FDA UDI	Class I	Active
Mpa Level 3	MPA 3 S V POTM	FDA UDI	Class I	Active
Acetaminophen Plus Low	ACETA+ LOW WB F LC	FDA UDI	Class I	Active
Lead Level 3 V4	LEAD 3 V4 WB F CH	FDA UDI	Class I	Active
Volatiles Qc Level 1	VOL QC 1 V2 U 2-PT LSA	FDA UDI	Class I	Active
Cys2uslp	CYS 2 U SLP	FDA UDI	Class I	Active
Busulfan Level 1	BUS 1 P F NIH	FDA UDI	Class I	Active
Benzodiazepines Level 2	BENZO 2 V2 U KP	FDA UDI	Class I	Active
Dau Calibrator 4	DAU CAL 4 F IUH	FDA UDI	Class I	Active
Trace Elements Level 1 V2	TRACE 1 V2 S QD	FDA UDI	Class I	Active
Methamphetamines Calibrator 1	METH CAL 1 U IMMU	FDA UDI	Class I	Active
Alprazolam Plus Calibrator Level 2	ALP+ CAL 2 V3 U F PT	FDA UDI	Class I	Active
Fentanyl Plus Level 3	FENT+ 3 V2 U NJSP	FDA UDI	Class I	Active
Positive Whole Blood	44600-WB(F) POS AFT	FDA UDI	Class I	Active
Immunosuppressants Blank	IMMUN 0 WB F UNC	FDA UDI	Class I	Active
Dau Calibrator 3	DAU CAL 3 F IUH	FDA UDI	Class I	Active
High Range AED II	72740	FDA UDI	Class I	Active
Drugs Of Abuse Level Cal 1	DAU C 1 F NHI	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.