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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 34 of 40

Device	Model / Reference	Registries	Class	Status
Aed Qc Level 1	UTAK-SC AED 1 SD	FDA UDI	Class I	Active
Lead Level 2	LEAD 2 WB F UMMC	FDA UDI	Class I	Active
Positive Defibrinated Plasma	POS P F LSA	FDA UDI	Class I	Active
Volatiles Lr	VOL LR MTL	FDA UDI	Class I	Active
Mpa Level 2	MPA 2 S V POTM	FDA UDI	Class I	Active
Md Labs 23 Level 1	MD LABS 23 1 V3 OF	FDA UDI	Class I	Active
Bus1700hup	BUS 1700 HUP	FDA UDI	Class I	Active
High Range Tricyclic Antidepressants VI	66316	FDA UDI	Class I	Active
Hmsu Mid Range	HMSU MR MAYO	FDA UDI	Class I	Active
Drugs Of Abuse Level	DAU CAL 2 V3 F NHI	FDA UDI	Class I	Active
Alprazolam Plus Calibrator Level 1	ALP+ CAL 1 V3 U F PT	FDA UDI	Class I	Active
Testosterone 100 Ng/Dl	TESTO 100 V3 S F PG	FDA UDI	Class I	Active
Oral Toxicology Qc Level 2	ORAL TOX QC2 5ML OF F GLML	FDA UDI	Class I	Active
Methylmalonic Acid 200 Nmol/L	MMA 200 QD	FDA UDI	Class I	Active
Lamotrigine Plus	LAMO+ V3 UPMC	FDA UDI	Class I	Active
Antid Level 1	ANTID 1 MAYO	FDA UDI	Class I	Active
Tox Ii_09 24	TOX II_09 24	FDA UDI	Class I	Active
Normal Range Trace Elements	66816 V2 NR LC	FDA UDI	Class I	Active
Dau High	DAU H F YNHH	FDA UDI	Class I	Active
Lead Level 4	LEAD 4 WB F LGC	FDA UDI	Class I	Active
Arsenic Plus Level 2	ARSEN+ 2 V2 U F LC	FDA UDI	Class I	Active
Etoh Ii_07 24	ETOH II_07 24	FDA UDI	Class I	Active
Morphine Pos	POS-213-2U	FDA UDI	Class I	Active
Oxazepam Glucuronide	OXA GLUC V2 U F HCMC	FDA UDI	Class I	Active
Busulfan Cal 3000 Ng/Ml	BUS CAL 3000 UCSF	FDA UDI	Class I	Active
Amphetamines High	AMPH H WB F TDPS	FDA UDI	Class I	Active
Dhea Level 2	DHEA 2 S F LC	FDA UDI	Class I	Active
Certified Drug Free Urine	88121-CDF(F)10 NJSP	FDA UDI	Class I	Active
Dau1ftdhs	DAU 1 F TDHS	FDA UDI	Class I	Active
Dau High	DAU V2 H QC SH	FDA UDI	Class I	Active
Drugs Of Abuse Level Cal 6	DAU C 6 F NHI	FDA UDI	Class I	Active
Testosterone Plus High	TESTO+ HIGH S F BRL	FDA UDI	Class I	Active
Hydroxychloroquine Level 1	HYDCHLOR 1 WB EBS	FDA UDI	Class I	Active
Busulfan Level 3 V2	BUS 3 V2 P F NIH	FDA UDI	Class I	Active
Nordiazepam 100 Ng/Ml	NORDIAZ 100 U F MED	FDA UDI	Class I	Active
Ethanol 80 Mg/Dl	ETH 80 WB F DOJ	FDA UDI	Class I	Active
Immunosuppressants Level 5	IMMU 5 WB WDL	FDA UDI	Class I	Active
B80088121sfa100mlf0	88121-SFA(100ML-F)	FDA UDI	Class I	Active
Clozapine Plus Qc 3	UTAK-SC CLOZ+ QC 3 V SD	FDA UDI	Class I	Active
Nicotine Plus Level 1	NIC+ 1 U F ADX	FDA UDI	Class I	Active
Antifungals Level 2	A-FUNG L2 S F MAYO	FDA UDI	Class I	Active
SMx SWEAT	SMX SWT 100 F UCSF	FDA UDI	Class I	Active
Oxa1smxuidc	OXA 1 SMX-U IDC	FDA UDI	Class I	Active
Alpt23 Etoh 09	ALPT23_ETOH 09	FDA UDI	Class I	Active
Certified Drug Free Urine 100 Ml	88121-CDF(L)100 ABS	FDA UDI	Class I	Active
Steroids Level 3 (SMx Serum)	51403	FDA UDI	Class I	Active
Voriconazole Plus Cal 1	VORI+ CAL 1 SJCR	FDA UDI	Class I	Active
Anti6v2sfunc	ANTI 6 V2 S F UNC	FDA UDI	Class I	Active
Daulowv4f2pttl	DAU LOW V4 F 2PT TL	FDA UDI	Class I	Active
Lorazepam Glucuronide 620 Ng/Ml	LORAZ GLUC 620 U F UCSD	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.