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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 2 of 40

Device	Model / Reference	Registries	Class	Status
Voriconazole Plus Cal 3	VORI+ CAL 3 SJCR	FDA UDI	Class I	Active
Oxazepam 10 Ng/M	POS-M120-1-2ML	FDA UDI	Class I	Active
Opiates 100 Ng/Ml	OPIA 100 S LHS	FDA UDI	Class I	Active
Opiates Urine Kit	POS-M245U-4-4	FDA UDI	Class I	Active
Certified Drug Free Urine	BLK U F 100 MAKO	FDA UDI	Class I	Active
Tepa Plus Level 3 V2	TEPA+ 3 V2 DP F MSKCC	FDA UDI	Class I	Active
Lamotrigine Plus Level 2	LAMO+ 2 V3 S UCH	FDA UDI	Class I	Active
Barbiturates Plus Level 1	BARBS+ 1 U V F RDL	FDA UDI	Class I	Active
Validity Check Mr	VAL MR U UK	FDA UDI	Class I	Active
Dau High Qc	DAU H QC F SH	FDA UDI	Class I	Active
Gabapentin Level 3	GABA 3 V3 SMXU F PG	FDA UDI	Class I	Active
Opiates Calibrator Level 4	OPI U CAL 4 UNC	FDA UDI	Class I	Active
Alpt23 09	ALPT23_09	FDA UDI	Class I	Active
Glycol Plus Level 2	GLYC+ 2 S F LSA	FDA UDI	Class I	Active
ETG Plus Level 1	13020	FDA UDI	Class I	Active
Lead Level 4	LEAD 4 WB F UMMC	FDA UDI	Class I	Active
Busulfan Qc Level 2	BUS QC 2 P F URMC	FDA UDI	Class I	Active
Testosterone Plus Level 2	TESTO+ 2 WB MTL	FDA UDI	Class I	Active
Digoxin Plus	DIGO10N V2	FDA UDI	Class I	Active
Antifungals Calibrator 5	ANTI 5 S F UNC	FDA UDI	Class I	Active
Busulfan 3500 Ng/Ml	BUS 3500 LP UCSF	FDA UDI	Class I	Active
Drugs Of Abuse	DA S ID	FDA UDI	Class I	Active
Haloperidol Plus Level 1	HALO+ 1 MAYO	FDA UDI	Class I	Active
Cannabinoids Calibrator 3	CANN CAL 3 U IMMU	FDA UDI	Class I	Active
Barbiturates Plus Level 2	BARBS+ 2 U V F RDL	FDA UDI	Class I	Active
Urine Broad Panel Mid	UBP M F DU	FDA UDI	Class I	Active
Bus 3500 Dp Mskcc	BUS 3500 DP MSKCC	FDA UDI	Class I	Active
Drugs Of Abuse Level 1 V4	DAU 1 V4 F RH	FDA UDI	Class I	Active
Anti5v2sfunc	ANTI 5 V2 S F UNC	FDA UDI	Class I	Active
Dau Positive	DAU POS U F BMC	FDA UDI	Class I	Active
Isavuconazole Plus Control 3 V2	ISA+ CONT 3 V2 S F UCSF	FDA UDI	Class I	Active
Xylazine Level 2	XYL 2 U F YNHH	FDA UDI	Class I	Active
7-Aminoclonazepam High	7-AMINO HIGH UPM	FDA UDI	Class I	Active
Thc Plus Level 8	THC+ 8 U F WCT	FDA UDI	Class I	Active
Vitamin D 40 Ng/Ml	VIT D 40 S ALV	FDA UDI	Class I	Active
Oxacalsmxuidc	OXA CAL SMX-U IDC	FDA UDI	Class I	Active
Buprenorphine Plus V4	UTAK-UC BUP V4 + SD	FDA UDI	Class I	Active
Drugs Of Abuse Calibrator 6	DAU CAL 6 U F NPIL	FDA UDI	Class I	Active
Diphenhydramine Pos Whole Blood	DIPH+ WB F PT	FDA UDI	Class I	Active
Pentobarbital Level 1	PENTO 1 S NCH	FDA UDI	Class I	Active
Buprenorphine Hydrolysis Qc	91801	FDA UDI	Class I	Active
Ethanol 50 Mg/Dl	ETH 50 V2 U UMMC	FDA UDI	Class I	Active
Drugs Of Abuse Qc A Level 3	QC A3 OF F WHPM	FDA UDI	Class I	Active
Mycophenolic Acid Glucuronide Level 2	MPAG 2 S MAYO	FDA UDI	Class I	Active
Clozapine Plus	CLOZ+ S AQ	FDA UDI	Class I	Active
Thc Level 1	THC U 1 F PG	FDA UDI	Class I	Active
Thc Plus Level 1	THC+ 1 V2 U NJSP	FDA UDI	Class I	Active
Drugs Of Abuse Calibrator V6	DOA CAL P OF V6	FDA UDI	Class I	Active
Antiblksfunc	ANTI BLK S F UNC	FDA UDI	Class I	Active
Daucal1v5fsemce	DAU CAL 1 V5 F SEMCE	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.