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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 27 of 40

Device	Model / Reference	Registries	Class	Status
Arachidic Acid Level 1 V2	ARA+ 1 V2 S ID	FDA UDI	Class I	Active
Certified Drug Free Urine	88121-CDF(L)50 PML	FDA UDI	Class I	Active
Qlod-Wb Level 1	QLOD-WB 1 NTL	FDA UDI	Class I	Active
Thc Level 2	THC 2 U F WDH	FDA UDI	Class I	Active
Smx Urine	36000-SMX-U(F)250	FDA UDI	Class I	Active
Alprazolam Plus Calibrator Level 3	ALP+ CAL 3 V3 U F PT	FDA UDI	Class I	Active
Defibrinated Plasma	44600-DAL10	FDA UDI	Class I	Active
Acetone 250 Mg/Dl	ACE 250 S F BSRHS	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DA OF 1 F ADX	FDA UDI	Class I	Active
Psych Qc 4 V3	PSYCH QC 4 V3 U F	FDA UDI	Class I	Active
Etoh I_05 25	ETOH I_05 25	FDA UDI	Class I	Active
Volatiles 150 Mg/Dl	VOL 150 WB	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 1	DA+1 WB V2 IMMUN	FDA UDI	Class I	Active
Dau Thc Plus Pcp Level 2	DAU THC+ 2 F OL	FDA UDI	Class I	Active
Testosterone 7.5 Ng/Dl	TESTO 7.5 V2 S F LCMS	FDA UDI	Class I	Active
Nida Cutoff	NIDA CUT V2 F CRL	FDA UDI	Class I	Active
Amphetamines Level 2	AMPH 2 U SQL	FDA UDI	Class I	Active
Md Labs 23 Level 1 V4	MD LABS 23 1 V4 OF	FDA UDI	Class I	Active
Dau Calibrator Level 3	DAU CAL 3 F ERSO	FDA UDI	Class I	Active
Immunosuppressants Level 1	IMMUNOS 1 WB F ARUP	FDA UDI	Class I	Active
Miscellaneous Panel Level 2	41431	FDA UDI	Class I	Active
Mitragynine Plus	MIT+ U F OT	FDA UDI	Class I	Active
Drugs Of Abuse Plus Level 1	DA+ 1 WB IMMUN	FDA UDI	Class I	Active
Tca Plus	TCA+ U CCL	FDA UDI	Class I	Active
Volatiles Plus 10 Mg/Dl	VOL+ 10 MFCL	FDA UDI	Class I	Active
Fentanyl Plus Level 5	FENT+ 5 U QD	FDA UDI	Class I	Active
Volatiles Plus 5 Mg/Dl	VOL+ 5 MFCL	FDA UDI	Class I	Active
Drugs Of Abuse Level 3	DAU 3 F OSUMC	FDA UDI	Class I	Active
Calibrator Vs 3	CAL VS 3 F M ACL	FDA UDI	Class I	Active
Drugs Of Abuse Level 1	DA 1 V2 WB NJSP	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	SMX-DAU 2 F PG	FDA UDI	Class I	Active
Ethanol Level 1	ETH 1 WB F UDH	FDA UDI	Class I	Active
Ethanol Bi-Level Set V2	ETH SET V2 WB CRL	FDA UDI	Class I	Active
Blank Whole Blood 50 Ml	44600-WB(F)50 UK	FDA UDI	Class I	Active
Calibrator A	CAL A U F SD	FDA UDI	Class I	Active
Anti3v2sfunc	ANTI 3 V2 S F UNC	FDA UDI	Class I	Active
Metals Low	METALS LOW S F EBS	FDA UDI	Class I	Active
Md Labs 43 Drugs Low	MD LABS 43 LOW	FDA UDI	Class I	Active
Amitriptyline Plus Level 1 V2	AMIT+ 1 V2 S SH	FDA UDI	Class I	Active
Aed Qc Level 2	UTAK-SC AED 2 SD	FDA UDI	Class I	Active
Drugs Of Abuse Level 2	DAU 2 F LE	FDA UDI	Class I	Active
Drugs Of Abuse Positive	DAU POS F KBI	FDA UDI	Class I	Active
Clobazam Plus Level 2	CLOB+ 2 V2 S F MAYO	FDA UDI	Class I	Active
Gabapentin Level 1	GABA 1 V3 SMXU F PG	FDA UDI	Class I	Active
Dexamethasone Level 3	DEXA 3 S F POTUS	FDA UDI	Class I	Active
Alpt23 08	ALPT23_08	FDA UDI	Class I	Active
Tapentadol Hydrolysis Qc	91805	FDA UDI	Class I	Active
Kit Dau	KIT DAU V2 POTM	FDA UDI	Class I	Active
Tox I_03 24	TOX I_03 24	FDA UDI	Class I	Active
Dihydrocodeine Level 1	DHC 1 WB UK	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.