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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
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2022375
DUNS Number
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Catalogue (1969)

Page 23 of 40
DeviceModel / ReferenceRegistriesClassStatus
Busulfan Level 1 V2 BUS 1 V2 P F EBS UK
FDA UDI
Class IActive
Benzodiazepines Level 2 V2 BENZO L2 V2 U F UW
FDA UDI
Class IActive
Busulfan Level 4 BUS C4 MAYO
FDA UDI
Class IActive
Drugs Of Abuse Level 1 SMX-DAU 1 V2 F PG
FDA UDI
Class IActive
Immunosuppressants Level 3 IMMU 3 WB WDL
FDA UDI
Class IActive
Miscellaneous Panel MP U F LSA
FDA UDI
Class IActive
Fentanyl Plus Level 2 FENT+ 2 U PM
FDA UDI
Class IActive
Trace Elements Qc Level 2 V2 TRACE QC 2 V2 S PAML
FDA UDI
Class IActive
Phenytoin Level 1 PHENY 1 S MCTL
FDA UDI
Class IActive
Voriconazole Plus Level 3 VORI+ 3 V2 S CMCD
FDA UDI
Class IActive
Drugs Of Abuse High V2 DAU HIGH V2 F PG
FDA UDI
Class IActive
Mycophenolic Acid Glucuronide Level 4 MPAG 4 S MAYO
FDA UDI
Class IActive
Nordiazepam 250 Ng/Ml NORDIAZ 250 S M
FDA UDI
Class IActive
Vitamin A Plus E Low 10081
FDA UDI
Class IActive
Miscellaneous Panel MP U F SCL
FDA UDI
Class IActive
Thc Plus Level 6 THC+ 6 U F WCT
FDA UDI
Class IActive
Creatinine Plus CREA+ PHAMA
FDA UDI
Class IActive
Lithium 15 Mmol/L LIT 15 S F BD
FDA UDI
Class IActive
Md Labs 43 Drugs High MD LABS 43 HIGH
FDA UDI
Class IActive
Busulfan Level 2 V2 BUS 2 V2 P F NIH
FDA UDI
Class IActive
Barbiturates Plus Low BARBS+ L S F LC
FDA UDI
Class IActive
Drugs Of Abuse Level 2 DOA 2 SMX-OF MMC
FDA UDI
Class IActive
Busulfan Level 1 V2 BUS 1 V2 P F NIH
FDA UDI
Class IActive
Buprenorphine Hydrolysis Qc 91801 U AL
FDA UDI
Class IActive
Antid Level 3 ANTID 3 MAYO
FDA UDI
Class IActive
Codeine-6-B-D-Glucuronide Plus COD GLUC+ U F DS
FDA UDI
Class IActive
Md Labs 23 Level 2 MD LABS 23 2 V3 OF
FDA UDI
Class IActive
Dau Level 1 DAU 1 V2 F SMA
FDA UDI
Class IActive
Buprenorphine Pos POS-236-2U
FDA UDI
Class IActive
Basic Qc BASIC QC
FDA UDI
Class IActive
Delta-9-Thc 8 Ng/Ml DELTA 9 OMEGA
FDA UDI
Class IActive
Thc Plus Level 5 THC+ 5 U F WCT
FDA UDI
Class IActive
Antifungal Qc Level 2 ANTIF QC 2 V2 LP F TF
FDA UDI
Class IActive
Buprenorphine Plus 40 Ng/Ml BUP+ 40 U PM
FDA UDI
Class IActive
Drugs Of Abuse Plus Level 4 DA+ 4 WB V4 IMMUN
FDA UDI
Class IActive
Opiates 500 Ng/Ml OPIA 500 U
FDA UDI
Class IActive
Amphetamine Cutoff AMPH CUT WB NC
FDA UDI
Class IActive
Vitamin D Plus Low VIT D+ L S KPRICH
FDA UDI
Class IActive
Nicotine Urine Level 2 NICOU L2 V2 MAYO
FDA UDI
Class IActive
Ethanol Bi-Level Set ETH SET S CRL
FDA UDI
Class IActive
MMA (Methylmalonic Acid) Level 2 74054
FDA UDI
Class IActive
Thc Qc THC QC U F NJSTL
FDA UDI
Class IActive
Drugs Of Abuse Positive Screen DAU POS U F PHHC
FDA UDI
Class IActive
B800daucont2frx0 DAU CONT 2 F RX
FDA UDI
Class IActive
Daucal1v4f2pttl DAU CAL 1 V4 F 2PT TL
FDA UDI
Class IActive
Immunosuppressants Level 1 IMMUN 1 WB F UNC
FDA UDI
Class IActive
Amphetamine Plus Level 2 V4 AMPH+ 2 U V4 F WBH
FDA UDI
Class IActive
Hmsb Level 2 HMSB 2 WB F MAYO
FDA UDI
Class IActive
Thc Plus Level 3 THC+ 3 WB 2PT F LSA
FDA UDI
Class IActive
Drugs Of Abuse Level 1 DAU QC 1 F MED
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.