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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 35 of 40

Device	Model / Reference	Registries	Class	Status
Haloperidol Plus Level 2	HALO+ 2 MAYO	FDA UDI	Class I	Active
B800zinc1rbcfqdva0	ZINC+ 1 RBC F QDVA	FDA UDI	Class I	Active
Nicotine Plus Level 1	90000 U F LTI	FDA UDI	Class I	Active
Busulfan Calibrator Level 5 V2	BUS CAL 5 V2 DP F MDACC	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	DOA 3 SMX-OF MMC	FDA UDI	Class I	Active
Barbiturates Plus Level 1	BARB+ 1 M F ACL	FDA UDI	Class I	Active
Drugs Of Abuse Positive	DAU POS F UPMC	FDA UDI	Class I	Active
Antifungals Level 1 V2	ANTIF 1 V2 F UVHS	FDA UDI	Class I	Active
Thc Cooh Hydrolysis Qc	91804 TRL	FDA UDI	Class I	Active
Mpa Level 1	MPA 1 S POTM	FDA UDI	Class I	Active
7-Aminos Plus Low	7-AMINO+ L U F DU	FDA UDI	Class I	Active
Miscellaneous Panel Level 1	41430	FDA UDI	Class I	Active
Acetaminophen Plus V3	ACETA+ U V3 BTL	FDA UDI	Class I	Active
Daucal3v5fsemce	DAU CAL 3 V5 F SEMCE	FDA UDI	Class I	Active
Volatiles 12.5 Mg/Dl	VOL 12.5 MMC	FDA UDI	Class I	Active
Denver Va Drugs Of Abuse Cal 2	DEN VA DAU CAL 2	FDA UDI	Class I	Active
Endo Level 2	STER 2 SMXS F SRL	FDA UDI	Class I	Active
Dau Low	DAU L F YNHH	FDA UDI	Class I	Active
Everolimus 8 Ng/Ml	EVER 8 WB F UCSF	FDA UDI	Class I	Active
6-Monoacetylmorphine Level 2	6-MAM 2 OF NAVIS	FDA UDI	Class I	Active
Leflunomide High Level 3	LEFLU HIGH L3 V2	FDA UDI	Class I	Active
Denver Va Drugs Of Abuse Cal 1	DEN VA DAU CAL 1	FDA UDI	Class I	Active
Qc Level 1 V3	QC V3 C-1 U F AP	FDA UDI	Class I	Active
SAMHSA Confirm Level 2	81821	FDA UDI	Class I	Active
Mpa Level 1	MPA 1 DP F FUMC	FDA UDI	Class I	Active
Immunoassay Cutoff	IA CUT U F PMG	FDA UDI	Class I	Active
Thc Plus Level 4	THC+ 4 U F WCT	FDA UDI	Class I	Active
Validity Control Level 4	17013	FDA UDI	Class I	Active
Methylmalonic Acid Level 2	MMA 2 S CHP	FDA UDI	Class I	Active
Volatiles Level 1	VOL 1 V2 S F RIH	FDA UDI	Class I	Active
Md Labs 43 Drugs Low	MD LABS 43 V2 LOW	FDA UDI	Class I	Active
Fentanyl Plus Level 1	FENT+ 1 U PM	FDA UDI	Class I	Active
SMx™ Oral Fluid	35400-SMX-OF(F)	FDA UDI	Class I	Active
DOA Cutoff (OF) Frozen	43051	FDA UDI	Class I	Active
Drugs Of Abuse Screen Negative	DAU NEG F QC VU	FDA UDI	Class I	Active
Selenium Qc High	SELEN QC H S F UCSD	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 V2 SAPC	FDA UDI	Class I	Active
Volatiles	AXIS VOL QC 1	FDA UDI	Class I	Active
Lamotrigine Plus Level 1	LAMO+ 1 S UPENN	FDA UDI	Class I	Active
Bromide 1500 Ug/Ml	BROM 1500 S CSU	FDA UDI	Class I	Active
Antifungals Calibrator 4	ANTI 4 S F UNC	FDA UDI	Class I	Active
Urine Cadmium Plus Level 2	CAD+ 2 U V NEP	FDA UDI	Class I	Active
Amphetamines Plus Be	AMPH+ BE U KPRICH	FDA UDI	Class I	Active
Buprenorphine Plus Level 2	BUP+ 2 U PM	FDA UDI	Class I	Active
Methotrexate Plus 3	METHO+ 3 S F MSKCC	FDA UDI	Class I	Active
Gabapentin Plus	GABA+ V V2 WB F MSP	FDA UDI	Class I	Active
Fentanyl Plus Level 2	FENT+ 2 V2 U NJSP	FDA UDI	Class I	Active
Immunoassay Level 1	IMMUNO 1 V2 ARUP	FDA UDI	Class I	Active
Cannabinoids Level 1	CAN 1 S F UWMC	FDA UDI	Class I	Active
Certified Drug Free Urine	CDF U L 250 OT	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.