CALBIOTECH, INC.

FDA Device Registration & Listing · El Cajon, CA, US · Registration 2090110

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
2090110
FEI Number
3002346973
Entity Name
CALBIOTECH, INC.
City/State/Country
El Cajon, CA, US
Establishment Address
1935 Cordell Ct, El Cajon, CA 92020, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Calbiotech, Inc. (Owner Number: 9046880)
Owner / Operator Contact Address
1935 Cordell Court, --, El Cajon, CA 92020, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Calbiotech SAR Various 14-3-3 eta; FLAER Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit Sumer Urine Drug Test Cup REAGENT GENERAL PURPOSE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2006-11-17
LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg Microbiology Class 1 866.3520 2024-09-16
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2024-09-16
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2023-04-04
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2024-09-16
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2024-09-16
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2023-04-04
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2023-04-04
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2024-04-04
LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus Microbiology Class 1 866.3380 2024-06-05
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2023-04-04
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2025-09-04
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2025-09-04
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2025-09-04
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2025-09-04
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2025-09-04
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2025-09-04
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2025-09-04
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2025-09-04
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2025-09-04
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2025-09-04
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2025-09-04
PPM General Purpose Reagent Pathology Class 1 864.4010 2006-11-16

Official Correspondent

DAVID BARKA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Calbiotech, 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
K954575 Abbott Laboratories AXSYM TOXO IGG ANTIBODY ASSAY 1996-08-16
K032162 Beckman Coulter, Inc. ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 2003-08-08
K000362 Zeus Scientific, Inc. MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM 2000-02-18
K250250 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Anti-Thyroid Peroxidase II 2025-10-17
K152061 Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material 2016-03-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-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-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 2090110. Last updated year: 2026. Please use registration number 2090110 when referencing this establishment in official correspondence.
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