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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 12 of 40

Device	Model / Reference	Registries	Class	Status
Urine Broad Panel High	UBP H F V DU	FDA UDI	Class I	Active
Busulfan Level 1	BUS 1 DP F DU	FDA UDI	Class I	Active
Tepa1dpfmskcc	TEPA+ 1 DP F MSKCC	FDA UDI	Class I	Active
Cotinine 100 Ng/Ml	COT 100 U F AHCH	FDA UDI	Class I	Active
Veterinary Use Only Bromide 0.5 Mg/Ml	VET BRO 0.5 S SD	FDA UDI	Class I	Active
Opiates Calibrator Level 5	OPI U CAL 5 UNC	FDA UDI	Class I	Active
Cotinine Level 2	COT 2 PM NT	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 1	DA+ 1 WB V3 IMMUN	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 3	DA+3 WB V2 IMMUN	FDA UDI	Class I	Active
Acetaminophen Plus V4	ACETA+ U V4 PM	FDA UDI	Class I	Active
Benzodiazepines Calibrator 3	BENZO CAL 3 U IMMU	FDA UDI	Class I	Active
Etg Plus Level 1	ETG+ 1 V2 U F CCL	FDA UDI	Class I	Active
Dau Qc Kit	DAU QC KIT V2 ABS	FDA UDI	Class I	Active
Denver Va Drugs Of Abuse Cal 6	DEN VA DAU CAL 6	FDA UDI	Class I	Active
Toxicology Uv High	TOX UV H S LC	FDA UDI	Class I	Active
Cortisol Cal	CORT SMX-OF F ARUP	FDA UDI	Class I	Active
Lorazepam Glucuronide 930 Ng/M	LORAZ GLUC 930 U F UCSD	FDA UDI	Class I	Active
Buprenorphine Cal Set	POS-M135-2-3	FDA UDI	Class I	Active
Dau Calibrator Level 7	DAU CAL 7 F ERSO	FDA UDI	Class I	Active
Dau Calibrator 8	DAU CAL 8 F IUH	FDA UDI	Class I	Active
Opiates Calibrator Level 3	OPI U CAL 3 UNC	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU L1 U F VMCI	FDA UDI	Class I	Active
Aed Qc Level 2 V3	UTAK-SC AED V3 2 SD	FDA UDI	Class I	Active
Aed Level 2 V3	AED 2 V3 S HCMC	FDA UDI	Class I	Active
Daucal5v4f2pttl	DAU CAL 5 V4 F 2PT TL	FDA UDI	Class I	Active
Codeine Gluc Plus Level 2	COD GLUC+ 2 U F YNHH	FDA UDI	Class I	Active
PM Plus High	91002	FDA UDI	Class I	Active
Spirits Level 1spirits Level 2	SPIRITS 2 S F OCMEO	FDA UDI	Class I	Active
Drugs Of Abuse B Level 1	DAU B 1 F BCPC	FDA UDI	Class I	Active
Certified Drug Free Urine	CDF U F 10 NJSP	FDA UDI	Class I	Active
Metals Level 1	MET 1 V S F UCSD	FDA UDI	Class I	Active
Etgcalv2mlb	ETG CAL V2 M LB	FDA UDI	Class I	Active
Dau Calibrator 2	DAU CAL 2 F IUH	FDA UDI	Class I	Active
Cotinine Plus 25 Ng/Ml	COT+ 25 S WDL	FDA UDI	Class I	Active
Validity Control Level 5	17014	FDA UDI	Class I	Active
Nicotine Plus 1200 Ng/Ml V3	NICO+ 1200 V3 U F UWHC	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 F APS	FDA UDI	Class I	Active
Psych Urine V3 Calibrator	PSY UR V3 CAL	FDA UDI	Class I	Active
Spirits Level 3	SPIRITS 3 S F OCMEO	FDA UDI	Class I	Active
Drugs Of Abuse Level 1 V2	DAU 1 V2 F SNC	FDA UDI	Class I	Active
Serum Drug Screen Level 2	DS 2 S ID	FDA UDI	Class I	Active
Tepa3dpfmskcc	TEPA+ 3 DP F MSKCC	FDA UDI	Class I	Active
Tox Ii_08 24	TOX II_08 24	FDA UDI	Class I	Active
Busulfan Level 4	BUS 4 V DP F DU	FDA UDI	Class I	Active
Infliximab Level 3	INFLIX QC 3 UPHS	FDA UDI	Class I	Active
Antidepressants Plus 400 Ng/Ml	ANTI+ 400 LC	FDA UDI	Class I	Active
Ethanol 80	ETH 80 S V F WVSP	FDA UDI	Class I	Active
Etg Plus Level 3	ETG+ 3 V2 U F CCL	FDA UDI	Class I	Active
Da Set 1 Cutoff	DA 1 CUT WB NC	FDA UDI	Class I	Active
Lead Level 3	LEAD 3 WB F UCI	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.