UCP BIOSCIENCES, INC.

FDA Device Registration & Listing · Milpitas, CA, US · Registration 3004987297

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004987297
FEI Number
3004987297
Entity Name
UCP BIOSCIENCES, INC.
City/State/Country
Milpitas, CA, US
Establishment Address
1900 Mccarthy Blvd Ste 204, Milpitas, CA 95035, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
UCP BIOSCIENCES, INC. (Owner Number: 9069635)
Owner / Operator Contact Address
1900 McCarthy Blvd STE 204, --, Milpitas, CA 95035, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

UCP Home Drug Screening Tests Identify Diagnostics Drug Test Cups Identify Diagnostics Drug Test Cards Identify ® Diagnostics Drug Test Cups, ID-CP12-BUP-AZ5 Identify ® Diagnostics Drug Test Cards, ID-CP10-DIP-AZ25 Identify ® Diagnostics Drug Test Cards, ID-CP5-DIP-AZ25 Identify ® Diagnostics Drug Test Cups, ID-CP10-AZ5 Identify ® Diagnostics Drug Test Cups, ID-CP5-AZ25 Identify ® Diagnostics Drug Test Cards, ID-CP5-DIP-AZ5 Identify ® Diagnostics Drug Test Cards, ID-CP10-DIP-AZ5 Identify ® Diagnostics Drug Test Cups, ID-CP12-BUP-AZ25 Identify ® Diagnostics Drug Test Cups, ID-CP12-BUP-AZ10 Identify ® Diagnostics Drug Test Cups, ID-CP12-BUP-AZ2 Identify ® Diagnostics Drug Test Cups, ID-CP12-BUP-ADULT Identify ® Diagnostics Drug Test Cups, ID-CP6-AZ5 Identify ® Diagnostics Drug Test Cups, ID-CP6-AZ25 Identify ® Diagnostics Drug Test Cards, ID-CP12-DIP-AZ5 Identify ® Diagnostics Drug Test Cups, ID-CP10-AZ25 Identify ® Diagnostics Drug Test Cards, ID-CP12-DIP-AZ25 UCP Drug Test Cup Scanner UCP Drug Test Cards UCP Multiple Drug Screen Cup UCP RAPID DRUG SCR UCP RAPID DRUG SCREENING Number One Flat Multi-Panel Drug Test Cup UCP Home Drug Screening Test Cups UCP Multi-Drug Test Key Cups UCP RAPID DRUG SCR UCP Drug Screening Test Cups

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2013-12-15
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2013-12-15
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2013-12-15
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2013-12-15
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2013-12-15
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2013-12-15
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2013-12-15
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2013-12-15
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2013-12-15
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2013-12-15
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2013-12-15
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2016-05-15
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2010-07-08
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2010-07-08
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2010-07-08
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2010-07-08
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2010-07-08
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2010-07-08
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2010-07-08
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2010-07-08
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2010-07-08
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2010-07-08
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2010-07-08
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2010-07-08
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2010-07-08
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2010-07-08
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2010-07-08
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2006-09-01
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2006-09-01
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2013-01-26
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2013-01-26
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2013-01-26
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2013-01-26
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2013-01-26
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2013-01-26
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2013-01-26
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2013-01-26
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2013-01-26
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2013-01-26
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2016-08-24
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2016-08-24
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2016-08-24
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2016-08-24
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2016-08-24
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2016-08-24
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2016-08-24
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2016-08-24
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2016-08-24
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2016-08-24
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2016-08-24
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2005-01-19
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2005-01-19
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2005-01-19
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2005-01-19
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2005-01-19
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2005-01-19
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2005-01-19
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2005-01-19
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2005-01-19
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2011-12-25
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2011-12-25
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2011-12-25
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2011-12-25
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2011-12-25
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2011-12-25
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2011-12-25
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2011-12-25
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2011-12-25

Official Correspondent

Shawn Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UCP BIOSCIENCES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K132630 Guangzhou Wondfo Biotech Co., Ltd. WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) 2013-09-27
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26
K151478 Guangzhou Wondfo Biotech Co., Ltd. Wondfo CR3 Keyless Split Sample Cup 2015-07-01
K150179 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 2015-02-25
K112310 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST,OPIATE TEST 2011-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2013 Alere San Diego, Inc. 2
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-2787-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004987297. Last updated year: 2026. Please use registration number 3004987297 when referencing this establishment in official correspondence.
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