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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 3 of 40

Device	Model / Reference	Registries	Class	Status
Testosterone 10 Ng/Dl	TESTO 10 V3 S F PG	FDA UDI	Class I	Active
6tgr Plus Qc Level 2	6TGR+ QC 2 UK	FDA UDI	Class I	Active
Cotinine Plus Level 1 V2	COT+ 1 V2 S LC	FDA UDI	Class I	Active
Flu1ufaht	FLU+ 1 U F AHT	FDA UDI	Class I	Active
Anti1v2sfunc	ANTI 1 V2 S F UNC	FDA UDI	Class I	Active
Ghb 20 Mg/L	GHB 20 U IN	FDA UDI	Class I	Active
Comp Tox I_01 25	COMP TOX I_01 25	FDA UDI	Class I	Active
Busulfan Level 3	BUS 3 P F EBS UK	FDA UDI	Class I	Active
Seco2fwbaht	SECO+ 2 F WB AHT	FDA UDI	Class I	Active
Pregnenolone Level 1	PREGN 1 S F BRL	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DOA 1 i2he OF F MMC	FDA UDI	Class I	Active
Vitamins 50 Nmol/L	VIT WB LC	FDA UDI	Class I	Active
Drugs Of Abuse Qc High	DAU QC HIGH F NPIL	FDA UDI	Class I	Active
Cotinine 1000 Ug/L	COT 1000 S IDC	FDA UDI	Class I	Active
Volatiles Plus 200 Mg/Dl	VOL+ 200 MFCL	FDA UDI	Class I	Active
Clozapine Plus Level 2	UTAK- SC CLOZ S F SD 2	FDA UDI	Class I	Active
Alprazolam Plus	ALPR+ U F BRL	FDA UDI	Class I	Active
Voriconazole Plus Cal 4	VORI+ CAL 4 SJCR	FDA UDI	Class I	Active
Nicotine Plus Level 2	NIC+ 2 U F UHCMC	FDA UDI	Class I	Active
Buprenorphine Plus Level 1	BUP+ 1 U F FML	FDA UDI	Class I	Active
Zinc Plus Level 2	ZINC+ 2 RBC F QDVA	FDA UDI	Class I	Active
Mma 10500 Nmol/L	MMA 10500 SJCLW	FDA UDI	Class I	Active
Opiates Calibrator 3	OPIA CAL 3 U IMMU	FDA UDI	Class I	Active
Amphetamine Plus Level 1	AMPH+ 1 U V3 F WBH	FDA UDI	Class I	Active
Mpa Plus Level 2	MPA+ 2 P V1 F UM	FDA UDI	Class I	Active
Dau Negative	DAU NEG V2 F CH	FDA UDI	Class I	Active
Etg Plus Qc Level 1 V2	ETG+ QC 1 V2 U F UCSF	FDA UDI	Class I	Active
Carbamazepine-10, 11-Epoxide Level 2	C1011 L2 V3	FDA UDI	Class I	Active
Anticonvulsants Mr	ANTI MR UPMC	FDA UDI	Class I	Active
Antifungals Level 2	43011	FDA UDI	Class I	Active
Thiocyanate 40 Mg/L	THIOC 40 V2 JH	FDA UDI	Class I	Active
Z Drugs Plus Level 2	41501	FDA UDI	Class I	Active
7-Aminos Plus Mid	7-AMINO+ M U F DU	FDA UDI	Class I	Active
Frozen Certified Drug Free Urine (2523ml)	88121-CDF(2523)	FDA UDI	Class I	Active
Dau-Iv	DAU IV FSCC	FDA UDI	Class I	Active
Volatiles (S) 2-Part	88119	FDA UDI	Class I	Active
Positive Whole Blood	POS WB F SP	FDA UDI	Class I	Active
Dauhighv4f2pttl	DAU HIGH V4 F 2PT TL	FDA UDI	Class I	Active
Antifungals Level 2 V2	ANTIF 2 V2 F UVHS	FDA UDI	Class I	Active
Dau Calibrator Kit	DAU CAL KIT ABS	FDA UDI	Class I	Active
Nordiazepam 100 Ng/Ml	NORDIAZ 100 S M	FDA UDI	Class I	Active
Adulterant Level 2	ADULT 2 U KP	FDA UDI	Class I	Active
Creatinine Level 1	CREAT 1 WB F LCG	FDA UDI	Class I	Active
Opiates Calibrator 4	OPIA CAL 4 U IMMU	FDA UDI	Class I	Active
Leflunomide V2 Low Level 1	LEFLU V2 L L1	FDA UDI	Class I	Active
Vitamin D Plus Level 2	VIT D+ 2 S KPRICH	FDA UDI	Class I	Active
Cocaine Plus 1000 Ng/Ml	COC+ 1000 SDHL	FDA UDI	Class I	Active
Daucal6v5fsemce	DAU CAL 6 V5 F SEMCE	FDA UDI	Class I	Active
Llof Level 1	LLOF 1 S F MAYO	FDA UDI	Class I	Active
Fentanyl Plus Level 2	FENT+ 2 U ADX	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.