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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 39 of 40

Device	Model / Reference	Registries	Class	Status
Daucal4v4f2pttl	DAU CAL 4 V4 F 2PT TL	FDA UDI	Class I	Active
Amitriptyline Plus	AMIT+ S WVHS	FDA UDI	Class I	Active
Nicotine Plus Level 1	NIC+ L1 U F PM	FDA UDI	Class I	Active
Clozapine 50 Ng/Ml V2	CLOZ 50 V2 UCI	FDA UDI	Class I	Active
Fentanyl Plus Level 1	FENT+ 1 U QD	FDA UDI	Class I	Active
Blank Serum	BLK S NC	FDA UDI	Class I	Active
Drugs Of Abuse Level 2 V3	DA 2 V3 WB LASD	FDA UDI	Class I	Active
Kit Dau	KIT DAU POTM	FDA UDI	Class I	Active
Drugs Of Abuse 1	DA 1 WB VTS	FDA UDI	Class I	Active
Amphetamine Plus Mid	AMPH+ M U F MAYO	FDA UDI	Class I	Active
Pregnenolone Level 2	PREGN 2 S F BRL	FDA UDI	Class I	Active
P/Z Qc V12 High	P/Z QC V12 H U F ML	FDA UDI	Class I	Active
4308 Level 1	430806C08	FDA UDI	Class I	Active
Steroids Level 4 (SMx Serum)	51404	FDA UDI	Class I	Active
Human Whole Blood Pool A	WB+ A F CTS 250	FDA UDI	Class I	Active
Drugs Of Abuse High	DAU H QC V3 UK	FDA UDI	Class I	Active
Arachidic Acid Level 3 V2	ARA+ 3 V2 S ID	FDA UDI	Class I	Active
Trace Elements Qc Level 2	TRACE QC 2 S PAML	FDA UDI	Class I	Active
Peth Level 7 V2	PETH 7 V2 WB F HFHS	FDA UDI	Class I	Active
Drugs Of Abuse Qc 3	DAU QC 3 V2 F BILH	FDA UDI	Class I	Active
High Range Trace Elements	66815	FDA UDI	Class I	Active
Drugs Of Abuse B Level 2	DAU B 2 F BCPC	FDA UDI	Class I	Active
Amitriptyline Plus Level 2	AMIT+ 2 V2 U F TRL	FDA UDI	Class I	Active
P/Z Calibrator V12	P/Z CAL V12 U F ML	FDA UDI	Class I	Active
Fentanyl Plus Level 3	FENT+ 3 U F MAYO	FDA UDI	Class I	Active
Buprenorphine Plus Level 2	BUP+ 2 U KP	FDA UDI	Class I	Active
Dau +25% Gcms	DAU +25 GCMS	FDA UDI	Class I	Active
Catecholamines Level 2	20208	FDA UDI	Class I	Active
Cotinine Pos	POS-217-2U	FDA UDI	Class I	Active
Busulfan Calibrator Level 5	BUS CAL 5 SJCR	FDA UDI	Class I	Active
Acid-Neut Qc	ACID-NEUT QC	FDA UDI	Class I	Active
Drugs Of Abuse Qc Low	DA QC LOW U F UMHC	FDA UDI	Class I	Active
Certified Drug Free Urine	88121-CDF(L)LTR WVDTL	FDA UDI	Class I	Active
Thc Plus Level 2	THC+ 2 WB 2PT F SDHL	FDA UDI	Class I	Active
Axis Vol Qc#3	AXIS VOL QC#3	FDA UDI	Class I	Active
Lead Level 4	LEAD 4 WB V WDL	FDA UDI	Class I	Active
Ethanol 80 1ml	ETH WB QC 80 V DOJ-1	FDA UDI	Class I	Active
Aldosterone Level 1	ALDO 1 F UVHS	FDA UDI	Class I	Active
Immunosuppressants Level 5	IMMUN 5 WB F UNC	FDA UDI	Class I	Active
Etg Plus Calibrator 6	ETG+ CAL 6 U F NPIL	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 V2 NJSP	FDA UDI	Class I	Active
Nicotine Plus Level 1	NICO+ 1 V2 F QC LC	FDA UDI	Class I	Active
Aldosterone Level 3	ALD 3 U F LC	FDA UDI	Class I	Active
Benzodiazepines 1000 Ng/Ml	BENZO 1000 U NKI	FDA UDI	Class I	Active
Dau Level 2	DAU 2 DTPM	FDA UDI	Class I	Active
Busulfan Level 1	BUS C1 MAYO	FDA UDI	Class I	Active
Toxicology Control	K810201	FDA 510(k)	Class I	Active
Tricyclic Antidepressants	K831736	FDA 510(k)	Class I	Active
Disopyramide N-Desalkyldisopyramide	K831740	FDA 510(k)	Class I	Active
Trace Elements Serum Toxicology Control	K883147	FDA 510(k)	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.