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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 26 of 40

Device	Model / Reference	Registries	Class	Status
Immunosuppressants Level 2	IMMUNO 2 F WB UW	FDA UDI	Class I	Active
Dau+ V2 F Ot	URINE PAIN PANEL	FDA UDI	Class I	Active
Carisoprodol Plus Level 2	CARIS+ 2 S QD	FDA UDI	Class I	Active
Thc Control 3	THC QC 3 U F WDH	FDA UDI	Class I	Active
Morphine Glucuronide Plus V4	MOR GLUC+ V4 U F USDTL	FDA UDI	Class I	Active
Drugs Of Abuse Calibrator 4	DAU CAL 4 U F NPIL	FDA UDI	Class I	Active
Buprenorphine Plus Level 2	BUP+ 2 U F FML	FDA UDI	Class I	Active
Volatiles	VOL U F OCMEO	FDA UDI	Class I	Active
Positive Control	POS CON 50 WB F EBS	FDA UDI	Class I	Active
Methamphetamines Urine Kit	POS-M220U-4-4	FDA UDI	Class I	Active
Clozapine Plus Calibrator	UTAK-SC CLOZ+ CAL V SD	FDA UDI	Class I	Active
Barbiturates Plus Level 2	BARB+ 2 M F ACL	FDA UDI	Class I	Active
Metals Level 1	MET 1 S MAYO	FDA UDI	Class I	Active
Blank Serum	44600	FDA UDI	Class I	Active
Methotrexate Level 2	METHO 2 S QD	FDA UDI	Class I	Active
Volatiles (WB) 2-Part	99119	FDA UDI	Class I	Active
Fentanyl Plus Level 4	FENT+ 4 V2 U NJSP	FDA UDI	Class I	Active
Pentobarbital 5 Ug/Ml	PENTO 5 JHH	FDA UDI	Class I	Active
Butalbital Plus 2 V2	BUTALBITAL+ 2 V2 AP	FDA UDI	Class I	Active
Benzodiazepines Plus 150 Ng/Ml	BENZO+ 150 VA	FDA UDI	Class I	Active
Dau -25% Gcms	DAU -25 GCMS	FDA UDI	Class I	Active
Urine Qc Low	U QC LOW V2 EL	FDA UDI	Class I	Active
Thc Level 6	THC 6 U F WDH	FDA UDI	Class I	Active
Dau Negative	DAU NEG U F BMC	FDA UDI	Class I	Active
Volatiles Plus 100 Mg/Dl	VOL+ 100 MFCL	FDA UDI	Class I	Active
Busulfan Level 3 V2	BUS 3 V2 P F EBS UK	FDA UDI	Class I	Active
Cannabinoids Calibrator 1	CANN CAL 1 U IMMU	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU L2 F KA	FDA UDI	Class I	Active
Dau2fv2p2l	DAU 2 F V2 P2L	FDA UDI	Class I	Active
Fentanyl Plus Level 3	FENT+ 3 S F MAYO	FDA UDI	Class I	Active
Urine Metals Level 1 V5	U MET 1 V5 F UK	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 V2 F APS	FDA UDI	Class I	Active
Dau Calibrator 6	DAU CAL 6 F IUH	FDA UDI	Class I	Active
Testosterone Level H	TESTO H SMX-S F UCH	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DOA 2 i2he OF F MMC	FDA UDI	Class I	Active
Cortisol Level 1	CORT 1 SMX-OF F PP	FDA UDI	Class I	Active
Alpt23 Etoh 10	ALPT23_ETOH 10	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DA OF 2 F PM	FDA UDI	Class I	Active
Benzodiazepines	BENZ U F KP	FDA UDI	Class I	Active
Total Psa 400 Ng/Ml	PSA 400 S F BD	FDA UDI	Class I	Active
Aluminum 18 Ug/L	ALUM 18 NR DV	FDA UDI	Class I	Active
Smx Cerebral Spinal Fluid	SMX CSF 50 NWMH	FDA UDI	Class I	Active
6tgr Plus Qc Level 1	6TGR+ QC 1 UK	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 2	DA+ 2 WB IMMUN	FDA UDI	Class I	Active
Steroids Level 2 (SMx Serum)	51402	FDA UDI	Class I	Active
Busulfan Cal 2000 Ng/Ml	BUS CAL 2000 UCSF	FDA UDI	Class I	Active
Tapentadol Plus Level 2	TAP+ 2 SMXU F PG	FDA UDI	Class I	Active
Normal Range Trace Elements V2	66816 NR V2 LC	FDA UDI	Class I	Active
Dhea Level 3	DHEA 3 S F LC	FDA UDI	Class I	Active
Methylmalonic Acid 1000 Nmol/L	MMA 1000 QD	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.