Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004140393

FEI Number

3004140393

Entity Name

BIOCARE MEDICAL, LLC

City/State/Country

Pacheco, CA, US

Establishment Address

60 Berry Drive, Pacheco, CA 94553, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

BIOCARE HOLDINGS, LLC (Owner Number: 9058052)

Owner / Operator Contact Address

3033 E. 1st Avenue, Suite 700, --, Denver, CO 80206, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PBS Plus, 10X Immunocare TBS Wash Buffer, 10X 20% Tween 20 TBS Automation Wash Buffer, 20X Immunocare PBS, 10X TBS Automation Wash Buffer,40X Tris Buffer Saline (TBS) Plus, 10X ONCORE Pro Wash Buffer Automation Tween 20, 20X IntelliPATH Max IntelliPATH Plus Progesterone Receptor (PR) [16] Progesterone Receptor (PR) [PgR636] Progesterone Receptor (PR) [SP2] Antigen Retrieval Chamber High Voltage (ARCHV) Antigen Retrieval Chamber High Voltage (ARCHV) - Recertified Rubens Eosin-Pholoxine Edgar Degas Eosin Estrogen Receptor (ER) [6F11] Estrogen Receptor (ER) [1D5] Estrogen Receptor (ER) [SP1] Estrogen Receptor (ER) [6F11 + SP1] CAT Hematoxylin intelliPATH Hematoxylin Tacha's Bluing Solution, 10X Tacha's Automated Hematoxylin Tacha's Bluing Solution RISH HybriSlips Copy Control 10 Green 6q21 Green COPY CONTROL 17 Green P504S-2X 20q13.2 Orange MYC (8q24) Green Copy Control 6q11.1 Aqua FGFR3 (4p16.3) Orange ATM (11q22.3) Aqua Copy Control 3 Aqua AMACR (RM), 2X COPY CONTROL 1p12 Green HPV Type 11 Probe (Digoxigenin) Copy Control 17 Aqua D13S25 (13q14.3) Orange HPV Type 51 Probe (Digoxigenin) RISHTM Cytomegalovirus (CMV) Probe Epstein-Barr Virus (EBV) Copy Control 7 Gold HHV-8 [13B10] HPV Type 18 Probe (Digoxigenin) RB1 (13q14.2) Green Copy Control 4q12 Green 5p15.2 Red P504S (P) Copy Control 12 Aqua Copy Control 7 Green ATM (11q22.3) Green HPV Type 6 Probe (Digoxigenin) RISH Epstein-Barr Encoded RNA (EBER) Probe Copy Control 12 Green Copy Control 7 Orange ATM (11q22.3) Orange RISH Kappa Light Chain DNA Probe Copy Control 15 Orange Cytomegalovirus (CMV) CCND1 (11q13) Orange RISH Lambda Light Chain DNA Probe Copy Control 4q12 Aqua AMACR (RM) COPY CONTROL 18 Aqua ERBB2 (17q12) Red IGH (14q32) Constant Orange 5p15.2 Green P504S (AMACR) (RM) [13H4] c-erbB-2/HER2 TP53 (17p13) Orange CDKN2A (9p21.3) Orange TERC (3q26.2) Red HPV Type 31 Probe (Digoxigenin) RB1 (13q14.2) Orange Progesterone Receptor (PR) [SP2] 20q13.2 Aqua MYB (6q23) Orange Progesterone Receptor (PR) [16] 1p21.2 Green FGFR3 (4p16.3) Aqua LAMP1 (13q34) Aqua HPV Type 16 Probe (Digoxigenin) Estrogen Receptor (ER) [6F11 + SP1] IGH (14q32) Green Estrogen Receptor (ER) [SP1] IGH (14q32) Variable Green D13S319 (13q14.2) Orange Progesterone Receptor (PR) [PgR636] 1q21.3 Orange LAMP1 (13q34) Green Copy Control 6q11.1 Green Helicobacter pylori Copy Control 7 Aqua HER2/neu [IHC042] Fluoro Care Anti-Fade Mountant Automation Tween 20, 20X TBS Automation Wash Buffer,40X Immunocare PBS, 10X TBS Automation Wash Buffer, 20X PBS Plus, 10X Tris Buffer Saline (TBS) Plus, 10X Immunocare TBS Wash Buffer, 10X ONCORE Pro Wash Buffer 20% Tween 20 c-erbB2/HER2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCC	Ph Buffer	Pathology	Class 1	864.4010	2015-01-20
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2004-11-01
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Hematology	Class 2	864.1860	2015-01-20
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-06-27
HYB	Eosin Y	Hematology	Class 1	864.1850	2012-05-15
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Hematology	Class 2	864.1860	2015-01-20
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2004-11-15
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2023-02-10
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2003-08-14
LEB	Mounting Media	Pathology	Class 1	864.4010	2015-01-20
MVC	System, Test, Her-2/Neu, Ihc	Unknown	Class 3	N/A	2022-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOCARE HOLDINGS, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-05	Zymed Laboratories Inc.	2	Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0015-05	Zymed Laboratories Inc.	2	Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004140393. Last updated year: 2026. Please use registration number 3004140393 when referencing this establishment in official correspondence.