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
Immunohistochemistry Reagents And Kits NJT

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