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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 6 of 40

Device	Model / Reference	Registries	Class	Status
Antifungals Level 2	A-FUNG L2 S F UW	FDA UDI	Class I	Active
Bismuth 10 Ug/L	BIS 10 U QD	FDA UDI	Class I	Active
Dau Calibrator Level 6	DAU CAL 6 V4 F SEMCE	FDA UDI	Class I	Active
Drugs Of Abuse Negative	DA NEG BM F MMB	FDA UDI	Class I	Active
SMx™ Serum	35700-SMX-S(F)	FDA UDI	Class I	Active
Peth Level 3	PETH 3 V2 WB F MAYO	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 4	ISA+ CAL 4 S F UCSF	FDA UDI	Class I	Active
Thc 150 Ng/Ml	THC 150 U PM	FDA UDI	Class I	Active
Amphetamine Plus 625 Ng/Ml V3	AMPH+ 625 V3 UCSF	FDA UDI	Class I	Active
Lead Level 3	LEAD 3 WB V WDL	FDA UDI	Class I	Active
Estrone Plus 400 Pg/Ml	ESTRO+ 400 S F BRL	FDA UDI	Class I	Active
Tca Panel	TCA U F NMS	FDA UDI	Class I	Active
Ccdkm Qc Level 2	CCDKM QC 2 WB UK	FDA UDI	Class I	Active
Arsenic Plus Level 2 V3	ARSEN+ 2 V3 U F LC	FDA UDI	Class I	Active
Methylmalonic Acid 500 Nmol/L	MMA 500 QD	FDA UDI	Class I	Active
Fentanyl Pos	POS-218-2U	FDA UDI	Class I	Active
Benzodiazepines Plus 100ng/mL	12090	FDA UDI	Class I	Active
Ssri 12 Level 2	92021 IDC	FDA UDI	Class I	Active
Isavuconazole Plus Control 2 V2	ISA+ CONT 2 V2 S F UCSF	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DOA 1 EXTBUF OF F MMC	FDA UDI	Class I	Active
Smx Whole Blood	SMX-WB 50 F ABB	FDA UDI	Class I	Active
Vitamin D Plus Low	10060	FDA UDI	Class I	Active
Clozapine Plus Qc 2	UTAK-SC CLOZ+ QC 2 V SD	FDA UDI	Class I	Active
Ethanol 150 Mg/Dl	ETH 150 WB F CMPD	FDA UDI	Class I	Active
Anti4v2sfunc	ANTI 4 V2 S F UNC	FDA UDI	Class I	Active
Urine Qc High	U QC HIGH V2 EL	FDA UDI	Class I	Active
Drugs Of Abuse 3	DA WB 3 V2 OCME	FDA UDI	Class I	Active
Drugs Of Abuse Qc Level 1	DA QC 1 OF PM	FDA UDI	Class I	Active
Drugs Of Abuse Cal Level 1	DAU+ L LEVEL 1 V3 URMC	FDA UDI	Class I	Active
Urine Qc Low	U QC LOW EL	FDA UDI	Class I	Active
Smx Vitreous Humor	SMX-VH(150) MCM	FDA UDI	Class I	Active
Iodine 20 Ug/L	IOD 20 PM	FDA UDI	Class I	Active
Glycols Level 2	UTAK-SC GLY 2 P SD	FDA UDI	Class I	Active
Benzodiazepines Level 1	BENZO L1 U F UW	FDA UDI	Class I	Active
Amphetamine Plus Level 2	AMPH+ 2 WB 2PT F V2 SDHL	FDA UDI	Class I	Active
Ethylene Glycol Level 1	ETHGLY 1 S F RIH	FDA UDI	Class I	Active
Smx Serum	SMX-S LTR F CDC	FDA UDI	Class I	Active
Clobazam Plus Level 1	CLOB+ 1 V2 S F MAYO	FDA UDI	Class I	Active
Tapentadol Plus Level 1	TAP+ 1 SMXU F PG	FDA UDI	Class I	Active
DHEA Plus High	51411	FDA UDI	Class I	Active
Lamotrigine Level 2	LAMO 2 S F UCI	FDA UDI	Class I	Active
Hallucinogens Level 1	HALL 1 U OGL	FDA UDI	Class I	Active
Busulfan Level 1	BUS 1 P F UK	FDA UDI	Class I	Active
Eia C1 V3	EIA C1 V3 WB DOJ	FDA UDI	Class I	Active
Vlgr Level 2	VLGR 2 S F MAYO	FDA UDI	Class I	Active
Clozapine Plus	CLOZ+ S NKI	FDA UDI	Class I	Active
Buprenorphine Plus Level 2	BUP+ 2 U ADX	FDA UDI	Class I	Active
7-Aminos Plus High	7-AMINO+ H U F DU	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 F HCMC	FDA UDI	Class I	Active
Pain Panel Urine	PAIN PAN U F ODX	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.