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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
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EUDAMED SRN
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FDA FEI Number
2022375
DUNS Number
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Catalogue (1969)

Page 28 of 40
DeviceModel / ReferenceRegistriesClassStatus
Opiates Low OPIA LOW U UNC
FDA UDI
Class IActive
Busulfan Level 2 BUS 2 P F UK
FDA UDI
Class IActive
Clozapine Plus CLOZ+ WB EBS
FDA UDI
Class IActive
Busulfan Cal 0 Ng/Ml BUS CAL 0 UCSF
FDA UDI
Class IActive
Voriconazole Level 1 VORI 1 DP QC DUM
FDA UDI
Class IActive
Etg Plus Qc Level 3 V2 ETG+ QC 3 V2 U F UCSF
FDA UDI
Class IActive
Testosterone Level 3 TESTO 3 S F MC
FDA UDI
Class IActive
Lead Level 2 LEAD 2 WB F UCI
FDA UDI
Class IActive
Thc Level 4 THC 4 U F WDH
FDA UDI
Class IActive
Dau High DAU H F TQHS
FDA UDI
Class IActive
Buprenorphine Plus Level 3 V2 BUP+ 3 V2 U F MAYO
FDA UDI
Class IActive
Dexamethasone Level 1 20197
FDA UDI
Class IActive
Xylazine Level 1 XYL 1 U F YNHH
FDA UDI
Class IActive
Etg Plus Mid ETG+ M MAYO
FDA UDI
Class IActive
Mycophenolic Acid Level 5 MPA 5 S MAYO
FDA UDI
Class IActive
Drugs Of Abuse Level 3 DOA 3 EXTBUF OF F MMC
FDA UDI
Class IActive
Opiates Low OPIA L S LC
FDA UDI
Class IActive
Tricyclics Level 2 TRIC 2 QDCHANT
FDA UDI
Class IActive
Isavuconazole Plus Calibrator 6 V2 ISA+ CAL 6 V2 S F UCSF
FDA UDI
Class IActive
Oxazepam 100 Ng/M POS-M120-2-2ML
FDA UDI
Class IActive
Drugs Of Abuse Plus Level 3 DA+ 3 WB V3 IMMUN
FDA UDI
Class IActive
Clofarabine Plus Level 2 CLOF+ 2 DP F MSKCC
FDA UDI
Class IActive
Ghb 20 Ug/Ml GHB 20 WB NJSP
FDA UDI
Class IActive
Lead Level 5 LEAD 5 WB F CH
FDA UDI
Class IActive
Thc Control 2 THC QC 2 U F WDH
FDA UDI
Class IActive
Methylmalonic Acid Plus Level 2 MMA+ 2 S F UCSD
FDA UDI
Class IActive
Pain Management Level 1 PM 1 U UCSF
FDA UDI
Class IActive
Cotinine 50 Ug/L COT 50 S IDC
FDA UDI
Class IActive
Buprenorphine Plus Level 1 BUP+ 1 U PM
FDA UDI
Class IActive
Arsenic Plus Level 3 V3 ARSEN+ 3 V3 U F LC
FDA UDI
Class IActive
Testosterone Level 3 TESTO 3 SMX-S F UCH
FDA UDI
Class IActive
Cbam Level 1 CBAM 1 V4 MAYO
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DAU 1 F OL
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DAU 1 F MED
FDA UDI
Class IActive
Drugs Of Abuse Qc 1 DAU QC 1 F BILH
FDA UDI
Class IActive
Oxycodone Plus Positive OXY+BUP POS F CH
FDA UDI
Class IActive
Drugs Of Abuse Level Cal 2 DAU C 2 F NHI
FDA UDI
Class IActive
Ethanol 200 Mg/Dl ETH 200 S CRL
FDA UDI
Class IActive
Common Path Qc 2 BENZU CP QC 2 V3
FDA UDI
Class IActive
Opiates Plus Mix OPI+ MIX ET
FDA UDI
Class IActive
Steroids Level 1 (SMx Serum) 51401
FDA UDI
Class IActive
Etg Plus Calibrator Level 1 ETG+ CAL 1 V2 U F UCSF
FDA UDI
Class IActive
Mma 500 Nmol/L MMA 500 F QD
FDA UDI
Class IActive
Busulfan Level 2 BUS 2 DP UPMC
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DA 1 S IDC
FDA UDI
Class IActive
Normal Human Serum 44600-S(500)
FDA UDI
Class IActive
Dextrorphan Plus DEXT+ U F KFR
FDA UDI
Class IActive
Qc Level 2 V3 QC V3 C-2 U F AP
FDA UDI
Class IActive
Benzodiazepines BENZO U UCI
FDA UDI
Class IActive
Iodine Level 3 IOD 3 S F SQ
FDA UDI
Class IActive

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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.