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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 37 of 40

Device	Model / Reference	Registries	Class	Status
DHEA Plus Low	51410	FDA UDI	Class I	Active
Urine Broad Panel High	UBP H F V DU	FDA UDI	Class I	Active
Drugs Of Abuse Low	DAU L F MAYO	FDA UDI	Class I	Active
Busulfan 500 Ng/Ml	BUS 500 LP UCSF	FDA UDI	Class I	Active
Etoh Ii_08 24	ETOH II_08 24	FDA UDI	Class I	Active
Busulfan Level 2	BUS 2 DP F DU	FDA UDI	Class I	Active
Busulfan Level 2 V2	BUS 2 V2 P F EBS UK	FDA UDI	Class I	Active
Opiates Plus Level 1	OPIA+ 1 WB SC	FDA UDI	Class I	Active
Benzodiazepines Urine Kit	POS-M120U-4-4	FDA UDI	Class I	Active
Busulfan Cal 5000 Ng/Ml	BUS CAL 5000 UCSF	FDA UDI	Class I	Active
Dexamethasone Level 3	20199	FDA UDI	Class I	Active
Dau Positive	DAU POS V2 F CH	FDA UDI	Class I	Active
Amphetamine Plus Level 2	AMPH+ 2 U V3 F WBH	FDA UDI	Class I	Active
Aluminum Level 2	ALUM 2 S BP	FDA UDI	Class I	Active
Ccdkm Qc Level 1	CCDKM QC 1 WB UK	FDA UDI	Class I	Active
Volatiles	VOL 2 WB F OCMEO	FDA UDI	Class I	Active
Benzodiazepines Level 2	BENZO L2 U F UW	FDA UDI	Class I	Active
Benzodiazepines Calibrator 4	BENZO CAL 4 U IMMU	FDA UDI	Class I	Active
Cotinine 1000 Ng/Ml	COT 1000 U F AHCH	FDA UDI	Class I	Active
Glucuronides	GLUC M F ACL	FDA UDI	Class I	Active
Toxicology Qc Level 1	TOX QC1 5ML U F GLML	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 5 V2	ISA+ CAL 5 V2 S F UCSF	FDA UDI	Class I	Active
Peth Level 4 V2	PETH 4 V2 WB F HFHS	FDA UDI	Class I	Active
Buprenorphine Plus Low	BUP+ LOW U KP	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 F OSUMC	FDA UDI	Class I	Active
Etg Plus Low	ETG+ LOW F SMXU NWMH	FDA UDI	Class I	Active
Blank Whole Blood	44600-WB(F)950	FDA UDI	Class I	Active
Tox Ii_10 24	TOX II_10 24	FDA UDI	Class I	Active
Drugs Of Abuse Low 3ml	DAU LOW V3 3ML U IPM	FDA UDI	Class I	Active
Tox Control 6	U TOX 6 RIH	FDA UDI	Class I	Active
Vitamins Level 2	VIT 2 S F ECLI	FDA UDI	Class I	Active
Carisoprodol Plus Level 1	CARIS+ 1 S QD	FDA UDI	Class I	Active
Antifungals Level 1	ANTIF 1 S WDL	FDA UDI	Class I	Active
Methotrexate Level 3	12105	FDA UDI	Class I	Active
6-Monoacetylmorphine Level 1	6-MAM 1 OF NAVIS	FDA UDI	Class I	Active
Morphine Glucuronide	MOR GLUC U HCMC	FDA UDI	Class I	Active
Thc Plus Level 2	THC+ 2 WB 2PT F LSA	FDA UDI	Class I	Active
Blank Whole Blood	44600-WB(F)	FDA UDI	Class I	Active
Peth Level 3	PETH 3 WB F HFHS	FDA UDI	Class I	Active
Opiate Positive Sample	OX POS SAMP	FDA UDI	Class I	Active
Blank Hair Matrix	BLK HAIR OL	FDA UDI	Class I	Active
Meperidine Plus Level 2	MEP+ 2 S LC	FDA UDI	Class I	Active
Drugs Of Abuse Cal	DA M CAL RDL	FDA UDI	Class I	Active
Voriconazole Level 2	VORI 2 DP QC DUMC	FDA UDI	Class I	Active
Methotrexate Level 1	METHO 1 S QD	FDA UDI	Class I	Active
Acetaminophen Plus 3	ACETA+ V3 3 S F BD	FDA UDI	Class I	Active
Busulfan Calibrator Level 6	BUS CAL 6 SJCR	FDA UDI	Class I	Active
Drugs Of Abuse Level 5	DAU 5 F LE	FDA UDI	Class I	Active
Opiates Calibrator Level 6	OPI U CAL 6 UNC	FDA UDI	Class I	Active
Chloride Plus Conductivity 2	CHL+ C 2	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.