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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 11 of 40

Device	Model / Reference	Registries	Class	Status
Elisa Low Positive Control	ELISA LPC WB OSBI	FDA UDI	Class I	Active
Psych Qc 3 V4	PSYCH QC 3 V4 U F	FDA UDI	Class I	Active
Thiocyanate Blank	THIOC BLK UW	FDA UDI	Class I	Active
Opiates High	OPIA HIGH U UNC	FDA UDI	Class I	Active
High Range Trace Elements V2	66815 HR V2 LC	FDA UDI	Class I	Active
Voriconazole Level 3	VORI 3 DP QC DUMC	FDA UDI	Class I	Active
Creatinine 100 Mg/Dl	CREA 100 SDRL	FDA UDI	Class I	Active
Drugs Of Abuse	DAU V2 S SH	FDA UDI	Class I	Active
Volatiles	UTAK SC-VOL S SOM	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 F APS	FDA UDI	Class I	Active
Arsenic Plus Level 2	ARSEN+ 2 WB QD	FDA UDI	Class I	Active
Buprenorphine Plus High	BUP+ H SMXU F PATH	FDA UDI	Class I	Active
Blank Whole Blood V2	BLK WB V2 NJSP	FDA UDI	Class I	Active
Etoh_01 24	ETOH I_01 24	FDA UDI	Class I	Active
Benzodiazepines Plus	BENZO+ WB VDFS	FDA UDI	Class I	Active
Hiv Infection Tdm Qc V3	HIV TDM QC V3 SL	FDA UDI	Class I	Active
Volatiles 400 Mg/Dl V2	VOL 400 WB F V2 HCMC	FDA UDI	Class I	Active
Urine Metals Level 3	U MET 3 V3 F UK	FDA UDI	Class I	Active
STABBS Positive	44510	FDA UDI	Class I	Active
Etoh I_03 25	ETOH I_03 25	FDA UDI	Class I	Active
Buprenorphine Plus Low	BUP+ L SMXU F PATH	FDA UDI	Class I	Active
Flurazepam Plus	FLURAZ+ U F SWI	FDA UDI	Class I	Active
Arsenic Plus Level 1	ARSEN+ 1 WB QD	FDA UDI	Class I	Active
Testosterone Level D	TESTO D SMX-S F UCH	FDA UDI	Class I	Active
Tricyclics Level 1	TRIC 1 QDCHANT V2	FDA UDI	Class I	Active
P/Z Calibrator	P/Z CAL U F ML	FDA UDI	Class I	Active
Positive Whole Blood	POS WB F JH	FDA UDI	Class I	Active
Anabasine Plus Level 2 V2	ANAB+ 2 V2 U LC	FDA UDI	Class I	Active
Urine Metals Level 2	U MET 2 V3 F UK	FDA UDI	Class I	Active
Dau Positive V2	DAU POS F V2 UVHS	FDA UDI	Class I	Active
Thc Plus Level 11	THC+ 11 U F WCT	FDA UDI	Class I	Active
Alprazolam Plus Level 3	ALP+ 3 V2 U F UK	FDA UDI	Class I	Active
Gabapentin Level 3	GABA 3 SMXU F PG	FDA UDI	Class I	Active
Benzodiazepines Qc V4	BENZO QC V4 FCCO	FDA UDI	Class I	Active
Smx Cerebral Spinal Fluid 1ml	SMX CSF F CP	FDA UDI	Class I	Active
Drugs Of Abuse Mid	DAU MID F PG	FDA UDI	Class I	Active
Dau Hc 2	50701	FDA UDI	Class I	Active
Metals Level 1	MET 1 V WB F UCSD	FDA UDI	Class I	Active
Thc Level 7	THC 7 U F WDH	FDA UDI	Class I	Active
Amphetamines Panel Level 2	41401	FDA UDI	Class I	Active
Tricyclics Level 2 V3	TCA L2 V3 S MAYO	FDA UDI	Class I	Active
Alprazolam Plus Qc Level 2	ALP+ QC 2 V3 U F PT	FDA UDI	Class I	Active
Da Set 1 Positive	DA 1 POS S NC	FDA UDI	Class I	Active
Custom UTAK QC Negative Fentanyl Panel	FENT + NEG U KP	FDA UDI	Class I	Active
Drugs Of Abuse Cal Level 2	DAU+ L LEVEL 2 V3 URMC	FDA UDI	Class I	Active
Ptzh C1	PTZH L1 MAYO	FDA UDI	Class I	Active
Mixed Control Level 1	CONTROL 1 S SH	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	SMX-DAU 3 F PG	FDA UDI	Class I	Active
Comp Tox I_05 25	COMP TOX I_05 25	FDA UDI	Class I	Active
Certified Drug Free Urine 500 Ml	88121-CDF(L)500 ML	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.