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 15 of 40

Device	Model / Reference	Registries	Class	Status
Sulfamethoxazole Plus Level 1	SUL+ 1 V3 MAYO	FDA UDI	Class I	Active
Ethanol 80 Mg/Dl	ETH 80 WB KCCL	FDA UDI	Class I	Active
Tca Panel Level 3	TCA 3 U WBH	FDA UDI	Class I	Active
Ethanol 300 Mg/Dl	ETH 300 WB WC	FDA UDI	Class I	Active
Vlgr Level 1	VLGR 1 S F MAYO	FDA UDI	Class I	Active
Etg Plus Calibrator 2	ETG+ CAL 2 U F NPIL	FDA UDI	Class I	Active
Voriconazole Plus Cal 2	VORI+ CAL 2 SJCR	FDA UDI	Class I	Active
Busulfan Level 3	BUS 3 P F NIH	FDA UDI	Class I	Active
Nicotine Plus Level 2	NIC+ 2 U F ADX	FDA UDI	Class I	Active
Daucal2v5fsemce	DAU CAL 2 V5 F SEMCE	FDA UDI	Class I	Active
Leflunomide High Level 1	LEFLU HIGH L1 V2	FDA UDI	Class I	Active
Immunosuppressants Qc 2	025090-0002	FDA UDI	Class I	Active
Qlod-Ur	QLOD-UR NTL	FDA UDI	Class I	Active
Rt3 Level 3	RT3 3 S F PG	FDA UDI	Class I	Active
Ethanol 20	ETHANOL 20	FDA UDI	Class I	Active
Certified Drug Free Urine	CDF U L(1/2 GAL) JNC	FDA UDI	Class I	Active
Immunosuppressants Level 6	IMMUN 6 WB F UNC	FDA UDI	Class I	Active
Etg Plus Level 2	ETG 2 U F KNH	FDA UDI	Class I	Active
Dau Low Qc	DAU L QC V3 F UHCMC	FDA UDI	Class I	Active
Normal Range Urine Metals	12111	FDA UDI	Class I	Active
Dau2fspc	DAU 2 F SPC	FDA UDI	Class I	Active
Metals Level 1	MET T 1 WB UK	FDA UDI	Class I	Active
Opiates Level 2	OPIA 2 U F UCD	FDA UDI	Class I	Active
Methotrexate 5 Umol/L	METHO 5 S UPHS	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 2 V2	ISA+ CAL 2 V2 S F UCSF	FDA UDI	Class I	Active
Lead 70 Ug/Dl	LEAD 70 WB ACL	FDA UDI	Class I	Active
Amiodarone Level 1	AMIO 1 S F QDVA	FDA UDI	Class I	Active
Lead Level 1	LEAD 1 WB F BCH	FDA UDI	Class I	Active
Volatiles	VOL U CCL	FDA UDI	Class I	Active
Dexamethasone Level 2	DEXA 2 S F PM	FDA UDI	Class I	Active
Combined	COMB M TCAO	FDA UDI	Class I	Active
Thc-Cooh 25 Ng/Ml	THC 25 U F SDHL	FDA UDI	Class I	Active
Toxicology Uv Low	TOX UV L S LC	FDA UDI	Class I	Active
Thc Plus Level 2	THC+ 2 V2 U NJSP	FDA UDI	Class I	Active
Busulfan Control Level 3	BUS CONT 3 SJCRH	FDA UDI	Class I	Active
Drugs Of Abuse Level Cal 3	DAU C 3 F NHI	FDA UDI	Class I	Active
Ethanol 20	ETH 20 U V F WVSP	FDA UDI	Class I	Active
Serum Drug Screen Level 4	DS 4 S ID	FDA UDI	Class I	Active
Isavuconazole Plus Calibrator 4 V2	ISA+ CAL 4 V2 S F UCSF	FDA UDI	Class I	Active
Urine Cadmium Plus Level 1	CAD+ 1 U V NEP	FDA UDI	Class I	Active
Oxy Thc Level 1	OXY THC 1 F OL	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DAU CAL 1 V3 F NHI	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DA 1 S SH	FDA UDI	Class I	Active
Metals Level 2	MET T 2 WB UK	FDA UDI	Class I	Active
Mpa Plus Level 3	MPA+ 3 LC	FDA UDI	Class I	Active
Dau Level 3	DAU 3 V8 F UVHS	FDA UDI	Class I	Active
Smx Cerebral Spinal Fluid	35100-SMX-CSF(F)	FDA UDI	Class I	Active
Methylmalonic Acid Level 1	MMA 1 S CHP	FDA UDI	Class I	Active
Thc Control 1	THC QC 1 U F WDH	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	DAU CAL 3 V3 F NHI	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.