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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 13 of 40

Device	Model / Reference	Registries	Class	Status
Busulfan 10 Ng/Ml	BUS 10 V P F CHLA	FDA UDI	Class I	Active
Drugs Of Abuse	DA V F WB SCCCL	FDA UDI	Class I	Active
Acetaminophen Plus High	ACETA+ HIGH V2 S F BD	FDA UDI	Class I	Active
Tramadol Pos	POS-225-2U	FDA UDI	Class I	Active
Barbiturates 500 Ng/Ml	BARBS 500 U MAYO V2	FDA UDI	Class I	Active
Testosterone 250 Nmol/L	TESTO 250 S F BD	FDA UDI	Class I	Active
Aluminum Plus Hr	ALUM+ HR P AC	FDA UDI	Class I	Active
Serum Drugs Level 1 V2	DRUGS 1 V2 S SH	FDA UDI	Class I	Active
Busulfan 100 Ng/Ml	BUS 100 V P F CHLA	FDA UDI	Class I	Active
Certified Drug Free Urine 500ml	88121-CDF(L) 500 VDFS	FDA UDI	Class I	Active
Smx Serum 6ml	35700-SMX-S(F)6ML NMH	FDA UDI	Class I	Active
Opiates Level 1 V2	OPIA 1 V2 U F CRL	FDA UDI	Class I	Active
Etoh I_04 24	ETOH I_04 24	FDA UDI	Class I	Active
Etg Plus Qc Mid	ETG+ QC MID U F NPIL	FDA UDI	Class I	Active
Dau Calibrator Level 6	DAU CAL 6 F ERSO	FDA UDI	Class I	Active
Whole Blood Matrix	BLK WB F CH	FDA UDI	Class I	Active
Acetaminophen Plus High	ACETA+ HIGH WB F LC	FDA UDI	Class I	Active
Benzoylecgonine Level 2	BENZOYL 2 F APTC	FDA UDI	Class I	Active
Barbiturates Level 2	BARBS 2 U UPENN	FDA UDI	Class I	Active
Morphine 100 Ng/M	pos-m245-3-2ml	FDA UDI	Class I	Active
Arsenic Plus Level 1	ARSEN+ 1 V2 U F LC	FDA UDI	Class I	Active
Bus 250 V P F Chla	BUS 250 V P F CHLA	FDA UDI	Class I	Active
Cortisol Level 2	CORT 2 SMX-OF F PP	FDA UDI	Class I	Active
Ghb 40 Ug/Ml	GHB 40 U NJSP	FDA UDI	Class I	Active
Antifungals Level 1	A-FUNG L1 S F UW	FDA UDI	Class I	Active
Lead Level 4 V3	LEAD 4 V3 WB F CH	FDA UDI	Class I	Active
Codeine Glucuronide Plus Level 1	COD GLUC+ 1 U PM	FDA UDI	Class I	Active
Dau Level 2 V2	DAU 2 V2 UCSD	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	DA 3 WB F RIDH	FDA UDI	Class I	Active
Daucal4v5fsemce	DAU CAL 4 V5 F SEMCE	FDA UDI	Class I	Active
Arsenic Plus Level 1	ARSEN+ 1 U F LC	FDA UDI	Class I	Active
Methamphetamine 25 Ng/Ml	POS-M220-1-2ML	FDA UDI	Class I	Active
Positive Whole Blood	POS WB F TDPS	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU 1 F HCMC	FDA UDI	Class I	Active
Volatiles Level 2	UTAK-WBC VOL 2 SD	FDA UDI	Class I	Active
Busulfan Calibrator Level 4 V2	BUS CAL 4 V2 DP F MDACC	FDA UDI	Class I	Active
Metanephrine Plus Low	META+ LOW PAML	FDA UDI	Class I	Active
Toxicology Qc Level 2	TOX QC2 5ML U F GLML	FDA UDI	Class I	Active
Opiates Plus Benzo Level 1	OPI+ BENZO 1 U F GML	FDA UDI	Class I	Active
Metals Level 2	MET 2 V S F UCSD	FDA UDI	Class I	Active
Kit Dau V4	KIT DAU V4 POTM	FDA UDI	Class I	Active
Veterinary Use Only Bromide 1.2 Mg/Ml	VET BRO 1.2 S SD	FDA UDI	Class I	Active
Thc Level 0	THC 0 U F WDH	FDA UDI	Class I	Active
Alpt23 10	ALPT23_10	FDA UDI	Class I	Active
Drugs Of Abuse	DA M QC RDL	FDA UDI	Class I	Active
Immunosuppressants Level 1	IMMU 1 V2 WB F PH	FDA UDI	Class I	Active
Lead Level 3	LEAD 3 WB F UMMC	FDA UDI	Class I	Active
Z Drugs Plus Level 1	41500	FDA UDI	Class I	Active
SMx URINE	SMXU 10 F UMPC	FDA UDI	Class I	Active
Tca Qc	TCA QC	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.