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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 21 of 40

Device	Model / Reference	Registries	Class	Status
4308 Level 2	430805C08	FDA UDI	Class I	Active
Eia Negative Calibrator	EIA NEG U F RX	FDA UDI	Class I	Active
Benzodiazepines Calibrator 1	BENZO CAL 1 U IMMU	FDA UDI	Class I	Active
Isavuconazole Plus Control 1 V2	ISA+ CONT 1 V2 S F UCSF	FDA UDI	Class I	Active
Certified Drug Free Urine 100ml	88121-CDF(F)100 PDH	FDA UDI	Class I	Active
Mpa Plus Level 1	MPA+ 1 P V1 F UM	FDA UDI	Class I	Active
Clozapine 1000 Ng/Ml V2	CLOZ 1000 V2 UCI	FDA UDI	Class I	Active
Methamphetamines Calibrator 2	METH CAL 2 U IMMU	FDA UDI	Class I	Active
Dau Calibrator Level 2	DAU CAL 2 V4 F SEMCE	FDA UDI	Class I	Active
Dau1fv2p2l	DAU 1 F V2 P2L	FDA UDI	Class I	Active
Lamotrigine Level 3	LAMO 3 S F UC	FDA UDI	Class I	Active
Dau B Level 1 V2	DAU B 1 V2 F IHL	FDA UDI	Class I	Active
Clofarabine Plus Level 3	CLOF+ 3 DP F MSKCC	FDA UDI	Class I	Active
Dau Level 2	DAU 2 V3 F SMA	FDA UDI	Class I	Active
Thc Cooh Hydrolysis Qc	91804	FDA UDI	Class I	Active
Seco1fwbaht	SECO+ 1 F WB AHT	FDA UDI	Class I	Active
Fentanyl Calibrator Level 2	FENT+ CAL 2 U F KP	FDA UDI	Class I	Active
Volatiles Level 2	VOL 2 V2 S F RIH	FDA UDI	Class I	Active
Busulfan Calibrator Level 6 V2	BUS CAL 6 V2 DP F MDACC	FDA UDI	Class I	Active
Drugs Of Abuse A Level 1	DAU A 1 F BCPC	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DA 1 WB F RIDH	FDA UDI	Class I	Active
Validity Control Level 3	17012	FDA UDI	Class I	Active
Fentanyl Calibrator Level 4	FENT+ CAL 4 U F KP	FDA UDI	Class I	Active
Benzodiazepines -25%	BENZO -25 ADX	FDA UDI	Class I	Active
Aluminum Plus Nr	ALUM+ NR P AC	FDA UDI	Class I	Active
Urine Metals Level 2	MET 2 U MAYO	FDA UDI	Class I	Active
Benzodiazepines Level 1 V3	BENZO L1 V3 U F UW	FDA UDI	Class I	Active
Dau Level 2	DAU 2 ABS	FDA UDI	Class I	Active
Validity Control Level 1	VAL 1 SH	FDA UDI	Class I	Active
Voriconazole Plus Qc 3	VORI+ QC 3 SJCR	FDA UDI	Class I	Active
Amphetamines Level 1	AMPH 1 U KP	FDA UDI	Class I	Active
Iodine Level 2	IOD 2 S F SQ	FDA UDI	Class I	Active
Mid Range Tricyclic Antidepressants VI	66317	FDA UDI	Class I	Active
Antifungals Level 2	ANTIF 2 S WDL	FDA UDI	Class I	Active
Chromium Plus Level 2	CHROM+ 2 WB QD	FDA UDI	Class I	Active
Benzoylecgonine 1	BE M 1 VTS	FDA UDI	Class I	Active
Amphetamines Panel Level 1	AMPH 1 U F UW	FDA UDI	Class I	Active
Buprenorphine Plus	UTAK-UC BUP+ U SD	FDA UDI	Class I	Active
Ph 11.5	PH 11.5 U PACTOX	FDA UDI	Class I	Active
Drugs Of Abuse Qc	DA+ QC M LB	FDA UDI	Class I	Active
Metals Level 2	MET 2 S MAYO	FDA UDI	Class I	Active
Hydroxybutyric 250 Ug/Ml	HYDROXYBUT 250 WB AM	FDA UDI	Class I	Active
Busulfan Calibrator Level 1 V2	BUS CAL 1 V2 DP F MDACC	FDA UDI	Class I	Active
Creatinine Plus	CREA+ A L DD	FDA UDI	Class I	Active
Clinical High V4	CLIN H V4 F BPC	FDA UDI	Class I	Active
Methadone Plus Metabolite	METH+ U NIRCL	FDA UDI	Class I	Active
SMx™ Urine	36000-SMX-U(F)	FDA UDI	Class I	Active
ETG Plus Level 2	13021	FDA UDI	Class I	Active
Everolimus 18 Ng/Ml	EVER 18 WB F UCSF	FDA UDI	Class I	Active
Opiates Level 2 V2	OPIA 2 V2 U F CRL	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.