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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 14 of 40

Device	Model / Reference	Registries	Class	Status
Drugs Of Abuse Low	DA LOW V2 WB F BTL	FDA UDI	Class I	Active
Blank Human Serum	BLK S 3 UW	FDA UDI	Class I	Active
Normal Human Serum 250ml	44600-S(250) ECMEO	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA 2 S IDC	FDA UDI	Class I	Active
Certified Drug Free Urine (Frozen)	88121-CDF(F)	FDA UDI	Class I	Active
Amphetamine Positive	AMPH POS S NC	FDA UDI	Class I	Active
Lamotrigine Plus 100 Ug/Ml	LAMO+ 100 S BCH	FDA UDI	Class I	Active
Busulfan 1000 Ng/Ml	BUS 1000 V P F CHLA	FDA UDI	Class I	Active
Fentanyl Calibrator Level 3	FENT+ CAL 3 U F KP	FDA UDI	Class I	Active
Fentanyl Plus Level 2	FENT+ 2 S F MAYO	FDA UDI	Class I	Active
Lamotrigine Plus Level 3	LAMO+ 3 S UPENN	FDA UDI	Class I	Active
Validity Check Low	VAL CHECK L CLH	FDA UDI	Class I	Active
Tox I_01 24	TOX I_01 24	FDA UDI	Class I	Active
Lead Level 5	LEAD 5 WB F LGC	FDA UDI	Class I	Active
Defibrinated Plasma	44600-D(5	FDA UDI	Class I	Active
Zolpidem Pos	POS-233-2U	FDA UDI	Class I	Active
Opiates Level 1	OPIA 1 U F UCD	FDA UDI	Class I	Active
Smx Meconium	SMX MEC 50 USDTL	FDA UDI	Class I	Active
Antifungals Level 1	43010	FDA UDI	Class I	Active
Aed Plus High	AED+ H S V2 SCH	FDA UDI	Class I	Active
Drugs Of Abuse Level Cal 5	DAU C 5 F NHI	FDA UDI	Class I	Active
Amphetamine Plus High	AMPH+ H S IDC	FDA UDI	Class I	Active
Drugs Of Abuse Calibrator 2	DAU CAL 2 U F NPIL	FDA UDI	Class I	Active
Iodine 200 Ug/L	IOD 200 V2 ADX	FDA UDI	Class I	Active
Metals Qc 2	UTAK-SC MET QC 2 S F SD	FDA UDI	Class I	Active
Fentanyl Plus Level 3	FENT+3 U QD	FDA UDI	Class I	Active
Mpa Level 2	MPA 2 DP F FUMC	FDA UDI	Class I	Active
Pm Panel Combo V9	PM PAN COM V9	FDA UDI	Class I	Active
Cotinine Plus Level 2	COT+ 2 S LC	FDA UDI	Class I	Active
P/Z Qc V12 Low	P/Z QC V12 L U F ML	FDA UDI	Class I	Active
Dau Level 1	DAU 1 V8 F UVHS	FDA UDI	Class I	Active
Blank Serum	BLK S SHC	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DOA 2 EXTBUF OF F MMC	FDA UDI	Class I	Active
Drugs Of Abuse +50%	DAU SCR +50 SAFE	FDA UDI	Class I	Active
Certified Drug Free Urine 100 Ml	88121-CDF(L)100 MM	FDA UDI	Class I	Active
Drugs Of Abuse Level 4	DAU CAL 4 V3 F NHI	FDA UDI	Class I	Active
Normal Range Trace Elements	66816	FDA UDI	Class I	Active
Trace Elements Qc Level 1 V2	TRACE QC 1 V2 S PAML	FDA UDI	Class I	Active
Lead Level 2	LEAD 2 WB F LGC	FDA UDI	Class I	Active
Pm 25 V3 U F Kp	PM 25 V3 U F KP	FDA UDI	Class I	Active
Blank Whole Blood	BLK WB NJSP	FDA UDI	Class I	Active
Dau Lc 2	50703	FDA UDI	Class I	Active
Blank Whole Blood	44600-WB(F)500	FDA UDI	Class I	Active
Oxycodone Plus Level 1	OXY+ 1 S F QDCHANT	FDA UDI	Class I	Active
Etg Plus Calibrator Level 3	ETG+ CAL 3 V2 U F UCSF	FDA UDI	Class I	Active
Vitamin D 80 Ng/Ml	VIT D 80 S ALV	FDA UDI	Class I	Active
Thc Plus Level 2	THC+ 2 V2 WB NJSP	FDA UDI	Class I	Active
Lamotrigine Level 1	LAMO 1 S F UCI	FDA UDI	Class I	Active
Amiodarone Plus 1 Ug/Ml	AMIO+ 1 MAYO	FDA UDI	Class I	Active
Metals Qc Level 2	MET QC 2 WB PAML	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.