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UTAK LABORATORIES, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
25020 AVENUE TIBBITTS, VALENCIA, CA, 91355
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
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FDA FEI Number
2022375
DUNS Number
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Catalogue (1969)

Page 24 of 40
DeviceModel / ReferenceRegistriesClassStatus
Positive Whole Blood POS WB 250 OT
FDA UDI
Class IActive
Vitamin B6 Level 1 VIT B6 1 S F UCD
FDA UDI
Class IActive
Clozapine 400 Ng/Ml CLOZ 400 S NYH
FDA UDI
Class IActive
Methamphetamine Cal Set POS-M2220-2-3
FDA UDI
Class IActive
Ghb 10 Ug/Ml GHB 10 U NJSP
FDA UDI
Class IActive
Nordiazepam 250 Ng/Ml NORDIAZ 250 U F MED
FDA UDI
Class IActive
Digitoxin Plus Level 2 DIGO+ 2 S LC
FDA UDI
Class IActive
Mpa Plus Level 2 MPA+ 2 LC
FDA UDI
Class IActive
Benzu Uncommon Path Qc 2 BENZU NCP PATH QC 2 V3
FDA UDI
Class IActive
Amphetamine Plus Level 1 AMPH+ 1 WB 2PT F V2 SDHL
FDA UDI
Class IActive
Busulfan Qc Level 3 BUS QC 3 F SHP BHM
FDA UDI
Class IActive
Oxa2smxuidc OXA 2 SMX-U IDC
FDA UDI
Class IActive
Eia C2 V3 EIA C2 V3 U F DOJ
FDA UDI
Class IActive
Thc 150 Ng/Ml THC 150 U ADX
FDA UDI
Class IActive
Drugs Of Abuse Screening Level 2 DAU 2 V2 IA QC
FDA UDI
Class IActive
Md Labs 43 Drugs High MD LABS 43 V2 HIGH
FDA UDI
Class IActive
Dau Qc Level 2 DAU QC 2 F ERSO
FDA UDI
Class IActive
Immunosuppressants Level 3 IMMUN 3 WB F UNC
FDA UDI
Class IActive
Adulterant Level 3 ADULT 3 U KP
FDA UDI
Class IActive
Dau Level 1 V3 DAU 1 V3 UCSD
FDA UDI
Class IActive
Smx Urine - Creatinine Free SMX-U BLK F LTDA
FDA UDI
Class IActive
Drugs Of Abuse High DAU H NIH
FDA UDI
Class IActive
Trace Elements Level 2 V2 TRACE 2 V2 S QD
FDA UDI
Class IActive
P/Z Calibrator V2 P/Z CAL V2 U F ML
FDA UDI
Class IActive
Thc Level 1 THC 1 U F WDH
FDA UDI
Class IActive
Alpt23 Etoh 08 ALPT23_ETOH 08
FDA UDI
Class IActive
Benzodiazepines 150 Ng/Ml BENZO 150 U F QDPA
FDA UDI
Class IActive
Alprazolam Plus Level 1 ALP+ 1 V2 U F UK
FDA UDI
Class IActive
Drugs Of Abuse Level 2 V4 DAU 2 V4 F RH
FDA UDI
Class IActive
Lead 2.5 Ug/Dl LEAD 2.5 WB ACL
FDA UDI
Class IActive
Vitamin A Plus E VIT A+E QC S CSU
FDA UDI
Class IActive
Qc Level 3 V3 QC V3 C-3 U F AP
FDA UDI
Class IActive
Ethanol 150 Mg/Dl ETH 150 WB F CCH
FDA UDI
Class IActive
Ph 3.5 PH 3.5 U PACTOX
FDA UDI
Class IActive
Therapeutic Monitoring Panel TDM U BTL
FDA UDI
Class IActive
Metals Level 1 MET 1 WB MAYO
FDA UDI
Class IActive
Opiates Level 2 OPIA 2 U UNC
FDA UDI
Class IActive
Dau Qc Level 3 DAU QC 3 F ERSO
FDA UDI
Class IActive
Drugs Of Abuse Plus Level 1 DAU + 1 F APC
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DAU L1 F KA
FDA UDI
Class IActive
Vitamin D Plus 150 Ng/Ml VIT D+ 150 S CH
FDA UDI
Class IActive
Daucal2v4f2pttl DAU CAL 2 V4 F 2PT TL
FDA UDI
Class IActive
Busulfan Qc Level 1 BUS QC 1 F SHP BHM
FDA UDI
Class IActive
Metals Level 2 44522
FDA UDI
Class IActive
Drugs Of Abuse Level 2 DAU 2 F OSUMC
FDA UDI
Class IActive
Vitamins Level 2 VIT L2 S MAYO
FDA UDI
Class IActive
Drugs Of Abuse Level 3 V2 DAU QC 3 V2 F NHI
FDA UDI
Class IActive
Benzodiazepines -25% BENZO -25 PM
FDA UDI
Class IActive
Volatiles VOL S F OCMEO
FDA UDI
Class IActive
Doxylamine Succinate 800 Ng/Ml DOXYL WB F NMS
FDA UDI
Class IActive

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Authorities

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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.

DateRecall No.ClassStatusReason
Mar 20, 2020Z-2407-2020—terminated

The product has an incorrect reference value for cadmium and an incorrect expected range.