Is this your brand? Sign in to claim ownership.

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 9 of 40

Device	Model / Reference	Registries	Class	Status
Drugs Of Abuse Level 4	DA 4 WB F RIDH	FDA UDI	Class I	Active
Benzoylecgonine Level 1	BENZOYL 1 F APTC	FDA UDI	Class I	Active
High Range Antipsychotics I	57044	FDA UDI	Class I	Active
Thiocyanate 15 Mg/L	THIOC 15 V2 JH	FDA UDI	Class I	Active
Nticonvulsants Hr	ANTI HR UPMC	FDA UDI	Class I	Active
Dau Qc Level 2	DAU QC 2 F CPSD	FDA UDI	Class I	Active
Busulfan Qc Level 2	BUS QC 2 F SHP BHM	FDA UDI	Class I	Active
Alprazolam Plus Qc Level 1	ALP+ QC 1 V3 U F PT	FDA UDI	Class I	Active
Opiates Level 3 V2	OPAT L3 V2 MAYO	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA OF 2 F ADX	FDA UDI	Class I	Active
Amiodarone Level 2	AMIO 2 S F QDVA	FDA UDI	Class I	Active
Aed Plus	AED+ S SCH	FDA UDI	Class I	Active
Barbiturates Qc	BARB+ QC M LB	FDA UDI	Class I	Active
Eia Calibrator Level 1	EIA CAL 1 U F RX	FDA UDI	Class I	Active
Mpa Plus Level 1	MPA+ 1 LC	FDA UDI	Class I	Active
Ethanol 300 Mg/Dl	ETH 300F WB LCCL	FDA UDI	Class I	Active
Etg Plus Calibrator Level 5	ETG+ CAL 5 V2 U F UCSF	FDA UDI	Class I	Active
Drugs Of Abuse Positive	DA POS BM F MMB	FDA UDI	Class I	Active
Buprenorphine Plus Qc Level 2	BUP+ QC 2 U TRL	FDA UDI	Class I	Active
Certified Drug Free Urine	CDF L 500 PM	FDA UDI	Class I	Active
Amines Low	AMINES H V2 CONT	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	DAU 3 F LE	FDA UDI	Class I	Active
Creatinine Baseline	CREAT BL WB F LCG	FDA UDI	Class I	Active
Opiates Level 2	OPI 2 U F VAMCI	FDA UDI	Class I	Active
Alprazolam Plus Level 2	ALP+ 2 V2 U F LENCO	FDA UDI	Class I	Active
Antifungals Calibrator 1	ANTI 1 S F UNC	FDA UDI	Class I	Active
Smx Urine	SMX-U 10 F UPMC	FDA UDI	Class I	Active
Drugs Of Abuse Qc A Level 2	QC A2 OF F WHPM	FDA UDI	Class I	Active
Fentanyl Assay Quality Control Material	FENT KIT U F	FDA UDI	Class I	Active
High Range Trace Elements	66815 V2 HR LC	FDA UDI	Class I	Active
Drugs Of Abuse Level 1 V3	DAU 1 V3 F VMG	FDA UDI	Class I	Active
Eia Calibrator Level 2	EIA CAL 2 U F RX	FDA UDI	Class I	Active
Drugs Of Abuse Cal	DA+ CAL M LB	FDA UDI	Class I	Active
Testosterone Level F	TESTO F SMX-S F UCH	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 V2 F U VMG	FDA UDI	Class I	Active
Thc Plus Level 3 V2	THC+ 3 U V2 NJSP	FDA UDI	Class I	Active
Thc Plus Level 1	THC+ 1 WB 2PT F LSA	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA 2 V2 F WB TDHS	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 3	DA+ 3 WB IMMUN	FDA UDI	Class I	Active
7 Product Number Product Description Pack Size Order Quantity Price Per Pack Ext	BARBS+ H S F LC	FDA UDI	Class I	Active
Defibrinated Plasma	DP 5 OVMC	FDA UDI	Class I	Active
Volatiles Plus Low	VOL+ L MCV	FDA UDI	Class I	Active
Immunosuppressants Level 3	IMMU 3 WB KPNH	FDA UDI	Class I	Active
Combined Opiates High	COMB OPIA HIGH U ADX	FDA UDI	Class I	Active
Etg Plus Calibrator 3	ETG+ CAL 3 U F NPIL	FDA UDI	Class I	Active
Drugs Of Abuse Qc	DAU QC F NSPCL	FDA UDI	Class I	Active
Drugs Of Abuse 1	DAU 1 PCL	FDA UDI	Class I	Active
High Range SSRI 7 Plus	57040	FDA UDI	Class I	Active
Cortisol Cal Level 2	CORT 2 SMX-OF F ARUP	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 V2 NJSP	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.