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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ph Buffer | JCC | Class 1 | Pathology | No | 2015-01-20 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2004-11-01 |
| Immunohistochemistry Assay, Antibody, Progesterone Receptor | MXZ | Class 2 | Hematology | No | 2015-01-20 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2024-06-27 |
| Eosin Y | HYB | Class 1 | Hematology | No | 2012-05-15 |
| Immunohistochemistry Antibody Assay, Estrogen Receptor | MYA | Class 2 | Hematology | No | 2015-01-20 |
| Hematoxylin | HYJ | Class 1 | Hematology | No | 2004-11-15 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2023-02-10 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2003-08-14 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2015-01-20 |
| System, Test, Her-2/Neu, Ihc | MVC | Class 3 | Unknown | No | 2022-06-02 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2004-11-15 |
| Test, Syphilis, Treponemal | MTN | Class N | Unknown | No | 2022-06-02 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2004-11-01 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2023-02-15 |
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