FDA Registration
Active
🇺🇸 United States
Bcl-2
Reg #: 3004140393
·
FEI: 3004140393
·
Expires 2025
Products
1
Proprietary Names
303
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOCARE MEDICAL, LLC
- Registration Number
- 3004140393
- FEI Number
- 3004140393
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2004-11-01 |
Proprietary Names
Bcl-2
CD1a [O10]
CK7
Cytokeratin 19 (CK19)
Folate Receptor alpha IHC Assay Kit
Ki-67 + Caspase-3
MCM2 + TOP2A
SOX11 (M)
BAP1
CD19
CK5/14 + p63 + CK7/18
Cytokeratin 17 (CK17)
Ki-67
MASH1
Prostate Specific Antigen (PSA)
SOX10 (M)
CD21
CD33
Cytokeratin 5/14 Cocktail
Galectin-3
Mesothelin
Napsin A
STAT6 [YE361]
TTF-1 + Napsin A
Carezyme III: Pronase Kit
CD8 [C8/1779R]
HPV-16 (CAMVIR-1)
OX40/CD134
PCNA [PC10]
PSAP [rACPP/1338]
Uroplakin III
ALK [5A4]
BRCA-1
CD117/c-kit
CD23
CDX2 (RM)
Collagen IV
Epidermal Growth Factor Receptor (EGFR)
Lambda Light Chain [N10/2]
S100P
Amyloid A
CD68 [KP1] BSA Free
CDX2 + CK7
Heat Shock Protein 70
IgG4 (M)
p40 (M)
Pan Lymphoma Cocktail (LCA+CD20+CD3+CD43)
Placental Alkaline Phosphatase (PLAP)
Chromogranin A
CD4 [4B12]
CD79a
Cytokeratin LMW (8/18)
GITR [CAL8]
HLA-DR [TAL 1B5]
NKX3.1
Pan TRK [RM423]
Uro-2 (CK20 + p53)
CD22 [BLCAM/1796]
CD34
Cytokeratin 5/6 (CK 5/6)
GATA-3
Microglia (Iba1)
Napsin A (RM)
Synaptophysin
TTF-1 + Napsin A (RM)
CD4 + CD8
CD8
Glial Fibrillary Acidic Protein (GFAP{M})
HMB45
NKX3.1 [D2Y1A]
PAX5
URO-3 Triple Stain (CD44+p53) with CK20
CD39 [EPR20627]
Cytokeratin 7 (CK7)
GATA-3 + Uroplakin II
Microphthalmia Transcription Factor (MiTF)
Nerve Growth Factor Receptor (NGFR)
Pan Melanoma + Ki-67
Terminal Deoxynucleotidyl Transferase (TdT {P})
Tumor Associated Glycoprotein [B72.3]
Ber-EP4
CD20 [L26]
CD31 (PECAM-1)
Cytokeratin 5 (CK5)
FOXP3 [86D]
Melanoma Cocktail
STAG1
TTF-1 + CK5
CA 19-9
CD137
CD3
CTLA-4
Epithelial Membrane Antigen (EMA) [E29]
LMO2 [SP51]
MLH-1 [BC23]
SATB2 [CL0323]
TIA-1
Carezyme I: Trypsin Kit
CD44
CD8 [C8/144B] BSA Free
HMW CK + p63 (Basal Cell Cocktail)
OCT 3/4 [N1NK]
PAX8 (M)
Uroplakin II + Uroplakin III
CD30 Cocktail
CD5 (M)
Desmoglein 3 + p40 (M) + Napsin A (RM)
Granzyme B
Muscle Specific Actin (MSA)
p16 + Ki-67
p63-2X
TTF-1
WT1 [rWT1/857]
Calretinin
CD3 [LN10]
CD45RO [UCHL-1]
Cytokeratin 14 (CK14)
Desmoglein 3 + CK5
ERG-2 (ERG + CK5)
Glutamine Synthetase
MSH6 [BC19]
p63 + CK5
Topoisomerase II alpha
CD4 (RM)
Cytokeratin HMW [34?E12]
GCDFP-15 + Mammaglobin
HIF-1 alpha
MLH-1
Neurofilament
Pan Melanoma Cocktail-2 (MART-1 and Tyrosinase)
Tyrosinase
CD10
CDH17 (M)
Claudin-4
Human IgG
Ki-67 + pHH3
PD-1 (RM)
ROR gamma T
CA-9
CD137 [BLR051F]
CD3 (P)
CTLA-4 [CAL49]
D2-40 (Lymphatic Marker)
ERCC1
Mammaglobin (M)
MOC-31
SMAD4 [EP618Y]
TIGIT (RM) [BLR047F]
Calponin
CD3 [BC33] BSA Free
Cytokeratin [AE1] LMW
Desmoglein 3
ERG (M), 2X
Glucagon
MART-1 + Tyrosinase + SOX10
MSH6
p63
TIM3 [BLR033F]
CD56
DOG1
Gross Cystic Disease Fluid Protein-15 (GCDFP-15) (Brst-2)
Myeloperoxidase
p16 + PRAME
Pan Cytokeratin [AE1/AE3]
pHH3 (RM)
TTF-1 [SPT24]
ZAP-70 (LR)
CD57 (Natural Killer Cell)
E-cadherin
H3K27me3 [C36B11]
IFNG [IFNG/3996R]
Myogenin
p16 INK4a [BC42]
Pan Cytokeratin [Lu-5]
PHOSPHO-EGFR
?-Catenin
BCA-225 [Cu-18]
CD19 (RM) [RM332]
CK5/14 + p63 + P504S
Cytokeratin 18 (CK18)
Ki-67 [MIB-1]
Mast Cell Tryptase [AA1]
Prostein
SOX10 [BC34] BSA Free
Bcl-6 [LN22]
CD20 [BC30]
CD31
CK8/18 (RM)
Cytokeratin 20 (CK20)
FOXP3
Melan A (M)
SOX2
Amyloid P
CD7
CEA (M)
Hepatocyte Specific Antigen (HSA)
IMP3 (RM)
p40 (M), 3X (Prostate)
PMS2
INSM1 [BLR272L]
ATRX
CD163
CK5 + p63
Kappa Light Chain [L1C1]
MART-1 Cocktail
p53
Prostate Cocktail (CK5 + CK14 + p63)
Smoothelin
Adipophilin
BRAF V600E [VE1]
CD103 (RM)
CDX2 (M) + CDH17 (RM)
c-Myc
E-Cadherin [CDH1/2208R]
IDO1
LAG3 [CAL26]
S100 Protein [4C4.9] (M)
CD43
CD8 [C8/144B]
Glial Fibrillary Acidic Protein (GFAP{P})
HMB45 + MART-1 + Tyrosinase
NPM1
PAX8
Uroplakin II
BOB-1
CD10 [UMAB236]
CDX2
Clusterin
IDH1 R132H [IHC132]
L26 + CD3
PD-L1
ROS1 [EPMGHR2]
Caspase-3 (Cleaved)
CD99
Human Chorionic Gonadotropin (Beta)
Ki-67 + CK7/8/18
p120 + E-cadherin
PD-1
PTEN (Tumor Suppressor)
CD68 [KP1]
CDX2 [BC39]
E-Cadherin (RM)
Hairy Cell Leukemia [DBA.44]
IGF-1R
P27 KIP1 [Y236]
Pan Cytokeratin Plus [AE1/AE3+8/18]
Phospho-Histone H3
PD-1 [CAL20]
Carcinoembryonic Antigen (CEA{M})
CD3 T-Cell (M)
CD45RO [UCHL-1] BSA Free
Desmoglein 3 + Napsin A
Factor VIII
Glycophorin A [JC159]
Mucin 5AC (Gastric Mucin)
p63 + TRIM29
TRBC1
Vimentin
CD30 (Ki-1)
CD47 [EPR21794]
Desmoglein 3 + p40 (M)
Factor XIIIa
Glypican-3
MUM-1
p120 Catenin
p63, 2X (Lung)
TRIM29
VISTA [BLR035F]
Arginase-1
CD138 + Cyclin D1
CK20
Kappa (M) + Lambda (P)
p40 [BC28] BSA Free
Prostate Cocktail 2X (CK5 + CK14 + p63)
Smooth Muscle Myosin Heavy Chain
NeoPATH Pro
Androgen Receptor
CD138
CD71
CK HMW + p63 + AMACR (RM)
Inhibin, Alpha
p40 (P)
PRAME [EPR20330]
TLE1 [EPR9386(2)]
Alpha-1-Fetoprotein (AFP)
Breast Cocktail (CK HMW/p63 + CK7/8/18)
CD11c (Leu-M5)
CD247 [BL-336-1B2]
COX-2
Epithelial Membrane Antigen (EMA [Mc-5])
Leukocyte Common Antigen (LCA) Cocktail
SALL4
Thyroglobulin Cocktail
Calcitonin
CD3 [BC33]
Cyclin D1
Desmin
ERG
MART-1 + Tyrosinase + pHH3
MSH2
p53 Tumor Suppressor Protein (M)
Smooth Muscle Actin (SMA)
TIGIT [BC41]
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device