FDA Registration Active 🇺🇸 United States

BIOCARE MEDICAL, LLC

Reg #: 3004140393 · FEI: 3004140393 · Expires 2026
Products
15
Proprietary Names
528
Establishment Types
4
Classifications
15

Registration Details

Registration Name
BIOCARE MEDICAL, LLC
Registration Number
3004140393
FEI Number
3004140393
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
60 Berry Drive
City
Pacheco
State
CA
ZIP
94553
Country
US

Owner / Operator

Firm Name
BIOCARE HOLDINGS, LLC
Operator Number
9058052
Address
3033 E. 1st Avenue, Suite 700, --
City
Denver
State
CO
Postal Code
80206
Country
US

Products

Device Name Product Code
Ph Buffer JCC
Slide Stainer, Automated KPA
Immunohistochemistry Assay, Antibody, Progesterone Receptor MXZ
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Eosin Y HYB
Immunohistochemistry Antibody Assay, Estrogen Receptor MYA
Hematoxylin HYJ
Coverslips, Microscope Slide KES
Reagents, Specific, Analyte MVU
Mounting Media LEB
System, Test, Her-2/Neu, Ihc MVC
General Purpose Reagent PPM
Test, Syphilis, Treponemal MTN
Immunohistochemistry Reagents And Kits NJT
Epstein-Barr Virus, Other LSE

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 20q13.2 Aqua MYB (6q23) Orange 1p21.2 Green FGFR3 (4p16.3) Aqua LAMP1 (13q34) Aqua HPV Type 16 Probe (Digoxigenin) IGH (14q32) Green IGH (14q32) Variable Green D13S319 (13q14.2) Orange 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 c-erbB2/HER2 Intellipath™ Background Punisher Renoir Red Diluent Background Terminator MACH 3 Rabbit HRP-Polymer Detection Fluorescence Antibody Diluent intelliPrep Solution Romulin AEC Chromogen Kit Hot Rinse, 25X ISH Retrieval (AR3) Slide Brite NeoPATH Pro Background Punisher 4plus Biotinylated Goat Anti-Rabbit IgG (Mouse and rat adsorbed) Deep Space Black™ Chromogen Kit I.E.D. Unit (Ion-Exchange Decal Unit) Nuclear Decloaker, 10X Protease XXIV 4plus Universal AP Detection Carezyme II: Pepsin Diva Decloaker, 20X ONCORE Pro ISHzyme Kit 4plus HRP Universal Detection Betazoid DAB Buffer MACH 4 Universal HRP-Polymer ONCORE Pro Fast Red Chromogen Kit Background Eraser Ferangi Blue™ Chromogen Kit 2 intelliPATH™ Warp Red™ Chromogen Kit RISH™ Retrieval, 10X Antigen Retrieval 2 (AR2), low pH DS Enzyme Kit ONCORE Pro-Tect Detection Kit Revival Series Sampler Antigen Retrieval 1 (AR1), high pH Da Vinci Green Diluent DNA Hybridization Buffer ONCORE Pro Warp Red Chromogen Kit Reveal Decloaker, RTU MACH 2 Double Stain 1 Starr Trek Universal HRP Detection Van Gogh Diluent intelliPATH FLX™ Peroxidase Blocking Reagent Renaissance Background Reducing Diluent DAB Away MACH 2 Rabbit AP-Polymer Mouse AP Detection Vulcan Fast Red Chromogen Kit 2 intelliPATH™ Ferangi Blue™ Chromogen Kit MACH 2 Rabbit HRP-Polymer Reveal Decloaker, 10X MACH 1 Universal HRP-Polymer Detection SSC Wash Buffer Universal Negative Control Serum MACH 2 Mouse AP-Polymer Mouse Amp HRP Detection V-Blocker Avidin-Biotin Kit Fast Red Chromogen Kit intelliPATH™ Universal HRP Detection Kit, 80-100 Tests Peroxidazed 1 RISH™ HRP Detection Kit 4plus Streptavidin HRP Label Borg Decloaker, RTU Diva Decloaker, 10X MACH 4™ Universal AP Polymer Kit ONCORE Pro ISH HRP Detection 4plus Biotinylated Universal Goat Link Denaturing Solution (Elution Step) intelliPATH FLX™ DAB Chromogen Kit Rabbit Amp AP Detection DAB Buffer Mouse HRP Detection Warp Red Chromogen Kit Dewax Solution Kit intelliPATH FLX™ Fast Red Chromogen Kit Rabbit AP Detection DAB Chromogen Multiplex Detection 1 ZipFISH™ Hybridization Buffer Diva Decloaker, 100X intelliPATH FLX™ Pepsin Rabbit HRP Detection DAB Chromogen Kit Multiplex Detection 2 Peroxidazed Diluent Aqua DePar, 10X EDTA Decloaker, 5X PeroxAbolish RISH™ AP Detection Kit Antigen Decloaker, 10X Chamber Cleaning Kit Diva Decloaker, RTU ONCORE Pro RISH™ Retrieval Kit intelliPATH™ Multiplex Secondary Reagent 2 MACH 2 Universal HRP-Polymer Detection 4plus Streptavidin AP Label Betazoid DAB Chromogen Kit MACH 4 Universal HRP-Polymer Detection System ONCORE Pro ISH Dewax Kit 4plus Biotinylated Goat Anti-Rabbit IgG DAB Substrate Buffer NeoPATH Pro Universal AP Polymer Kit Pronase Buffer 4plus Biotinylated Goat Anti-Mouse IgG DAB Sparkle NeoPATH Pro Pepsin Polymer Negative Control Serum (Mouse & Rabbit) MACH 2 Mouse HRP-Polymer Mouse anti-Digoxigenin VP Monet Blue Diluent Bajoran Purple Chromogen Kit MACH 4 Universal AP Detection System ONCORE Pro DAB Chromogen Background Sniper MACH 3 Rabbit AP-Polymer Detection MACH 2 Double Stain 2 Monet Blue Diluent Tubing Cleaning Kit Van Gogh Yellow Diluent intelliPATH™ Negative Control (ER/PR) MACH 3 Mouse AP-Polymer Detection Background Punisher intelliPATH™ Universal HRP Detection Kit MACH 3 Mouse HRP-Polymer Detection Antigen Retrieval Chamber Decloaking Chamber Pro™ Decloaking Chamber™ NxGen DESERT CHAMBER PRO™ Treponema pallidum (Spirochete) CD4 (RM) CD79a Cytokeratin HMW [34?E12] GCDFP-15 + Mammaglobin HIF-1 alpha NeoPATH Pro Pan Lymphoma Cocktail (LCA+CD20+CD3+CD43) TTF-1 + CK5 CD3 T-Cell (M) CD47 [EPR21794] Desmoglein 3 + Napsin A Factor VIII Glycophorin A [JC159] MSH6 [BC19] OCT 3/4 [N1NK] p63 TIGIT [BC41] URO-3 Triple Stain (CD44+p53) with CK20 CD30 (Ki-1) CD5 (M) Desmoglein 3 + p40 (M) Glypican-3 Mucin 5AC (Gastric Mucin) OX40/CD134 p63 + CK5 TIM3 [BLR033F] Uroplakin II Calcitonin CD3 [BC33] Cyclin D1 Desmin ERG Glial Fibrillary Acidic Protein (GFAP{P}) Mammaglobin (M) MOC-31 p40 [BC28] BSA Free Thyroglobulin Cocktail CD57 (Natural Killer Cell) DOG1 Gross Cystic Disease Fluid Protein-15 (GCDFP-15) (Brst-2) IDO1 Muscle Specific Actin (MSA) p120 Catenin p63, 2X (Lung) PD-1 (RM) Uroplakin III CD20 [L26] CD31 (PECAM-1) Cytokeratin 5 (CK5) FOXP3 [86D] Melan A (M) Myeloperoxidase SOX10 [BC34] BSA Free TRBC1 CD21 CD33 Cytokeratin 5/14 Cocktail Galectin-3 Melanoma Cocktail Myogenin SOX11 (M) TRIM29 MTAP [A8N9F] Adipophilin BRAF V600E [VE1] CD103 (RM) CD22 [BLCAM/1796] CDX2 (RM) c-Myc E-Cadherin [CDH1/2208R] L26 + CD3 PTEN (Tumor Suppressor) Androgen Receptor CD138 CK HMW + p63 + AMACR (RM) Inhibin, Alpha p40 (M) Phospho-Histone H3 SALL4 ?-Catenin Alpha-1-Fetoprotein (AFP) CD68 [KP1] BSA Free CDX2 + CK7 Hairy Cell Leukemia [DBA.44] Bcl-6 [LN22] IGF-1R CD20 [BC30] CD31 Cytokeratin 20 (CK20) p16 + PRAME Pan Cytokeratin [AE1/AE3] PD-L1 FOXP3 VISTA [BLR035F] MCM2 + TOP2A SOX10 (M) Topoisomerase II alpha BAP1 CD19 CK5/14 + p63 + CK7/18 Cytokeratin 17 (CK17) Kappa Light Chain [L1C1] MART-1 Cocktail PRAME [EPR20330] Smooth Muscle Actin (SMA) ATRX CD163 CK5 + p63 CD39 [EPR20627] Cytokeratin 7 (CK7) GATA-3 + Uroplakin II Cytokeratin 14 (CK14) Hepatocyte Specific Antigen (HSA) Kappa (M) + Lambda (P) MART-1 + Tyrosinase + SOX10 PMS2 Microglia (Iba1) Napsin A (RM) SMAD4 [EP618Y] Pan Cytokeratin Plus [AE1/AE3+8/18] TTF-1 [SPT24] CA-9 CD3 (P) CTLA-4 [CAL49] D2-40 (Lymphatic Marker) ERCC1 LMO2 [SP51] MLH-1 [BC23] p40 (P) S100P Terminal Deoxynucleotidyl Transferase (TdT {P}) Carcinoembryonic Antigen (CEA{M}) CD43 CD8 [C8/144B] BSA Free HMB45 + MART-1 + Tyrosinase NKX3.1 Pan TRK [RM423] Tumor Associated Glycoprotein [B72.3] Calponin CD3 [BC33] BSA Free CD44 Cytokeratin [AE1] LMW Desmoglein 3 ERG (M), 2X CD34 Glucagon MSH2 Cytokeratin 5/6 (CK 5/6) p53 GATA-3 TIA-1 Mesothelin Napsin A Pan Cytokeratin [Lu-5] SOX2 TTF-1 CD4 [4B12] CD8 GITR [CAL8] HLA-DR [TAL 1B5] Nerve Growth Factor Receptor (NGFR) Pan Melanoma + Ki-67 TTF-1 + Napsin A Bcl-2 CD1a [O10] CD30 Cocktail CK7 Cytokeratin 19 (CK19) Folate Receptor alpha IHC Assay Kit Mast Cell Tryptase [AA1] Smoothelin Amyloid P CD137 [BLR051F] CD71 Chromogranin A IMP3 (RM) P27 KIP1 [Y236] PHOSPHO-EGFR ZAP-70 (LR) ALK [5A4] BRCA-1 CD117/c-kit CD23 Collagen IV Epidermal Growth Factor Receptor (EGFR) LAG3 [CAL26] ROR gamma T STAG1 Carezyme I: Trypsin Kit CD8 [C8/1779R] HMW CK + p63 (Basal Cell Cocktail) NKX3.1 [D2Y1A] PAX5 Prostate Cocktail – 2X (CK5 + CK14 + p63) Tyrosinase Breast Cocktail (CK HMW/p63 + CK7/8/18) CD11c (Leu-M5) CD247 [BL-336-1B2] COX-2 Epithelial Membrane Antigen (EMA [Mc-5]) Lambda Light Chain [N10/2] Microphthalmia Transcription Factor (MiTF) ROS1 [EPMGHR2] STAT6 [YE361] Carezyme III: Pronase Kit CD99 HPV-16 (CAMVIR-1) Ki-67 [MIB-1] NPM1 PAX8 Prostate Cocktail (CK5 + CK14 + p63) CA 19-9 CD137 CD3 CTLA-4 Cytokeratin LMW (8/18) Epithelial Membrane Antigen (EMA) [E29] Leukocyte Common Antigen (LCA) Cocktail MLH-1 S100 Protein [4C4.9] (M) Synaptophysin Caspase-3 (Cleaved) CDH17 (M) CK8/18 (RM) Human Chorionic Gonadotropin (Beta) Ki-67 + Caspase-3 PAX8 (M) Prostate Specific Antigen (PSA) BCA-225 [Cu-18] CD19 (RM) [RM332] CK5/14 + p63 + P504S Cytokeratin 18 (CK18) Factor XIIIa Ki-67 MASH1 Smooth Muscle Myosin Heavy Chain Arginase-1 CD138 + Cyclin D1 CK20 INSM1 [BLR272L] MART-1 + Tyrosinase + pHH3 p40 (M), 3X (Prostate) Placental Alkaline Phosphatase (PLAP) SATB2 [CL0323] Calretinin CD3 [LN10] CD45RO [UCHL-1] Desmoglein 3 + CK5 ERG-2 (ERG + CK5) Glutamine Synthetase MSH6 p53 Tumor Suppressor Protein (M) TIGIT (RM) [BLR047F] Uro-2™ (CK20 + p53) Amyloid A CD7 CEA (M) Heat Shock Protein 70 IgG4 (M) p16 INK4a [BC42] pHH3 (RM) WT1 [rWT1/857] BOB-1 CD10 [UMAB236] CDX2 (M) + CDH17 (RM) Clusterin E-Cadherin (RM) IDH1 R132H [IHC132] Ki-67 + pHH3 PSAP [rACPP/1338] Ber-EP4 CD10 CDX2 Claudin-4 Human IgG Ki-67 + CK7/8/18 PCNA [PC10] Prostein PGP9.5 [UCLH1/4556R] CD4 + CD8 CD8 [C8/144B] Glial Fibrillary Acidic Protein (GFAP{M}) HMB45 Neurofilament Pan Melanoma Cocktail-2 (MART-1 and Tyrosinase) TTF-1 + Napsin A (RM) CD68 [KP1] CDX2 [BC39] E-cadherin H3K27me3 [C36B11] IFNG [IFNG/3996R] p16 + Ki-67 p63-2X PD-1 [CAL20] Vimentin CD56 Desmoglein 3 + p40 (M) + Napsin A (RM) Granzyme B MUM-1 p120 + E-cadherin p63 + TRIM29 PD-1 TLE1 [EPR9386(2)] Uroplakin II + Uroplakin III

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only