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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 19 of 40

Device	Model / Reference	Registries	Class	Status
Metals Level 3	44523	FDA UDI	Class I	Active
Drug Mix	DM M IGENO	FDA UDI	Class I	Active
Volatiles Low	UTAK-SC VOL+ LOW SD	FDA UDI	Class I	Active
Tricyclics Pos	POS-222-2U	FDA UDI	Class I	Active
Busulfan Control Level 2	BUS CONT 2 SJCRH	FDA UDI	Class I	Active
Ethylene Glycol Plus 25 Mg/Dl	ETHGLY+ 25 UI	FDA UDI	Class I	Active
Drugs Of Abuse	DA WB 2PT V2 SDHL	FDA UDI	Class I	Active
Dau 36 Low	DAU 36 LOW UPM	FDA UDI	Class I	Active
Dau1fspc	DAU 1 F SPC	FDA UDI	Class I	Active
Drugs Of Abuse Positive V2	DAU POS V2 F UPMC	FDA UDI	Class I	Active
Whole Blood	111120-WB(F)2.5	FDA UDI	Class I	Active
Certified Drug Free Urine	88121-CDF(L)400	FDA UDI	Class I	Active
Validity Control Level 3	VAL 3 SH	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 2	DA+ 2 WB V3 IMMUN	FDA UDI	Class I	Active
Acetone Blank	ACE BLK S F BSRHS	FDA UDI	Class I	Active
Dau Calibrator Level 5	DAU CAL 5 V4 F SEMCE	FDA UDI	Class I	Active
Benzodiazepines	BENZO U WVHS	FDA UDI	Class I	Active
Volatiles	VOL 1 WB F OCMEO	FDA UDI	Class I	Active
Nicotine Urine Level 3	NICOU L3 V2 MAYO	FDA UDI	Class I	Active
Metals Qc 3	UTAK-SC MET QC 3 S F SD	FDA UDI	Class I	Active
Busulfan Calibrator Level 4	BUS CAL 4 SJCR	FDA UDI	Class I	Active
Methotrexate Plus 2	METHO+ 2 S F MSKCC	FDA UDI	Class I	Active
Aed Level 1 V3	AED 1 V3 S HCMC	FDA UDI	Class I	Active
Denver Va Pain Level 1	DEN VA PAIN 1 V4	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 ID	FDA UDI	Class I	Active
Thc Plus Level 9	THC+ 9 U F WCT	FDA UDI	Class I	Active
Dau Ia 2	50601	FDA UDI	Class I	Active
7-Aminoclonazepam Low	7-AMINO LOW MDL	FDA UDI	Class I	Active
Lead Level 3	LEAD 3 WB F LGC	FDA UDI	Class I	Active
Volatiles Plus Low	VOL+ L V2 HMC	FDA UDI	Class I	Active
Ethanol 150	ETH 150 WB V F WVSP	FDA UDI	Class I	Active
Buprenorphine Plus Level 2 V2	BUP+ 2 V2 U F MAYO	FDA UDI	Class I	Active
Selenium 200 Ug/L	SELEN 200 S BP	FDA UDI	Class I	Active
Testosterone Level G	TESTO G SMX-S F UCH	FDA UDI	Class I	Active
Dau Positive V4	DAU POS F V4 UVHS	FDA UDI	Class I	Active
Leflunomide V2 Low Level 2	LEFLU V2 L L2	FDA UDI	Class I	Active
Tox Ii_06 24	TOX II_06 24	FDA UDI	Class I	Active
Benzodiazepines Level 2	BENZO L2 U F UW	FDA UDI	Class I	Active
Drugs of Abuse Level 1	98818	FDA UDI	Class I	Active
Cotinine Plus Level 1	COT+ 1 S LC	FDA UDI	Class I	Active
Selenium 100 Ug/L	SELEN 100 S BP	FDA UDI	Class I	Active
Drugs Of Abuse High	DAU H V2 F MAYO	FDA UDI	Class I	Active
Tof High	TOF HIGH WB PM	FDA UDI	Class I	Active
Urine Qc High V4	U QC HIGH V4 EL	FDA UDI	Class I	Active
Drugs Of Abuse Level Cal 4	DAU C 4 F NHI	FDA UDI	Class I	Active
Fentanyl Plus Level 2	FENT+ 2 WB NJSP	FDA UDI	Class I	Active
Drugs Of Abuse Negative Screen V2	DAU NEG V2 U F PHHC	FDA UDI	Class I	Active
Denver Va Pain Level 3	DEN VA PAIN 3 V4	FDA UDI	Class I	Active
Adulterant Level 1	ADULT 1 U KP	FDA UDI	Class I	Active
Carbamazepine-10, 11-Epoxide Level 2	C1011 L2 V4	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.