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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 10 of 40

Device	Model / Reference	Registries	Class	Status
Etoh Ii_09 24	ETOH II_09 24	FDA UDI	Class I	Active
Dau Low Qc	DAU L QC F SH	FDA UDI	Class I	Active
Clozapine 500 Ng/Ml	CLOZ 500 S NYH	FDA UDI	Class I	Active
Vitamin B6 Level 2	VIT B6 2 S F UCD	FDA UDI	Class I	Active
Normal Human Serum	44600-S(MAYO)	FDA UDI	Class I	Active
Lsd Pos	POS-215-2U	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 3	ISA+ CAL 3 S F UCSF	FDA UDI	Class I	Active
Digitoxin Plus Level 1	DIGO+ 1 S LC	FDA UDI	Class I	Active
Lamotrigine Plus Level 2	LAMO+ 2 S ARUP	FDA UDI	Class I	Active
Opiates Level 3	OPI 3 U F VAMCI	FDA UDI	Class I	Active
Etg Plus Calibrator Level 6	ETG+ CAL 6 V2 U F UCSF	FDA UDI	Class I	Active
Voriconazole Plus Level 2	VORI+ 2 V2 S CMCD	FDA UDI	Class I	Active
Methotrexate Level 1	12103	FDA UDI	Class I	Active
Drugs Of Abuse Level 2 V2	DAU 2 V2 F CSL	FDA UDI	Class I	Active
Iodine Qc Level 3	IOD QC 3 U QDVA	FDA UDI	Class I	Active
Endo Level 3	STER 3 SMXS F SRL	FDA UDI	Class I	Active
Drugs Of Abuse Kit	DAU KIT DTPM	FDA UDI	Class I	Active
Dau Mid Qc	DAU M QC V3 F UHCMC	FDA UDI	Class I	Active
7-Amino Plus 100 Ng/Ml	7-AMINO+ 100 MP	FDA UDI	Class I	Active
Methotrexate Level 4	12106	FDA UDI	Class I	Active
Clozapine Plus Qc 1	UTAK-SC CLOZ+ QC 1 V SD	FDA UDI	Class I	Active
Busulfan Low	BUS L SP F TCH	FDA UDI	Class I	Active
Vitamin D 4 Ng/Ml	VIT D 4 S ALV	FDA UDI	Class I	Active
Etg Plus Calibrator 1	ETG+ CAL 1 U F NPIL	FDA UDI	Class I	Active
Amitriptyline Plus 800 Ng/Ml	AMIT+ 800 U SL	FDA UDI	Class I	Active
Amphetamines Level 1	AMPH 1 U SQL	FDA UDI	Class I	Active
Dau Calibrator Level 1	DAU CAL 1 F ERSO	FDA UDI	Class I	Active
Lamotrigine Plus Level 3	LAMO+ 3 V3 S UCH	FDA UDI	Class I	Active
Urine Broad Panel High	UBP H F DU	FDA UDI	Class I	Active
Thc Level 11	THC 11 U F WDH	FDA UDI	Class I	Active
Etg Plus Qc Low	ETG+ QC LOW U F NPIL	FDA UDI	Class I	Active
Glucuronides Hydrolysis Qc V2	GLUC QC V2 U CCHS	FDA UDI	Class I	Active
Arsenic Plus Level 2	ARSEN+ 2 U F LC	FDA UDI	Class I	Active
Benzoylecgonine Cal Set	POS-M150-2-3	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA 2 WB F RIDH	FDA UDI	Class I	Active
Methamphetamines Calibrator 4	METH CAL 4 U IMMU	FDA UDI	Class I	Active
Methanol Plus 1	METH+ 1 UCD	FDA UDI	Class I	Active
Lead Level 3	93313	FDA UDI	Class I	Active
Drugs Of Abuse Level 1 V3	DA 1 V3 WB LASD	FDA UDI	Class I	Active
PM Plus Low	91000	FDA UDI	Class I	Active
Chloroquine Plus Level 1	CHLOR+ WB F 1 EBS	FDA UDI	Class I	Active
Vitamins Level 3	VIT L3 S MAYO	FDA UDI	Class I	Active
Pain Management Plus	PM+ U F CCL	FDA UDI	Class I	Active
Etg Plus Calibrator Level 4	ETG+ CAL 4 V2 U F UCSF	FDA UDI	Class I	Active
Barbiturates Cal Set	POS-M115-2-3	FDA UDI	Class I	Active
Pain Management 100	21070	FDA UDI	Class I	Active
Human Whole Blood Pool B	WB+ B F CTS 250	FDA UDI	Class I	Active
Peth Level 3	PETH 3 V3 WB F MAYO	FDA UDI	Class I	Active
Mid Range SSRI 7 Plus	57041	FDA UDI	Class I	Active
Fentanyl Negative	FENT NEG F CH	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.