FDA Registration
Active
🇨🇳 China
CELNOVTE BIOTECHNOLOGY CO., LTD
Reg #: 3015614371
·
FEI: 3015614371
·
Expires 2026
Products
7
Proprietary Names
347
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- CELNOVTE BIOTECHNOLOGY CO., LTD
- Registration Number
- 3015614371
- FEI Number
- 3015614371
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 1 Cuizhu Street, Bldg 109, Hi-tech District , Zhengzhou City,Henan,China
- City
- zhengzhou Henan
- Country
- CN
Owner / Operator
- Firm Name
- Celnovte Biotechnology Co., Ltd
- Operator Number
- 10090201
- Address
- NO. 1 Cuizhu Street, Bldg 109, Hi-tech District , Zhengzhou City,Henan,China
- City
- zhengzhou
- State
- Henan
- Postal Code
- 450000
- Country
- CN
- Correspondent
- Hua Qi
US Agent
- Business Name
- CELNOVTE BIOTECHNOLOGY, Inc
- Contact Name
- xin qi
- Address
- 9430 Key West Ave Ste 150
- City
- Rockville
- State
- MD
- ZIP
- 20850
- Country
- US
- [email protected]
- Phone
- 401 4414689
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2024-03-04 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2024-04-02 |
| Mucicarmine | HZC | Class 1 | Hematology | No | 2024-12-06 |
| Reagent, Schiff | HZT | Class 1 | Hematology | No | 2024-12-06 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-04-08 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2024-04-08 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2024-04-08 |
Proprietary Names
Fully Automatic IHC Staining System
Fully Automatic Multi-functional Stainer and Coverslipper
Fully Automatic Immunohistochemistry Stainer
Fully Automatic Special Stainer and Coverslipper
Fully Automatic IHC Stainer
Fully Automatic Liquid-Based Cytology & Immunocytochemistry Stainer
SMA (C1C1), MMab
pan-CK/p63 Cocktail Antibody
CD45RO (UCHL1), MMab
Elastic fiber stain kit
NKX3.1 (MyR1-NKX3.1), RMab
Kappa Light Chain (C8H10), MMab
PD-L1 (C9C9), MMab
CD123 (6H6), MMab
ACTH (Polyclonal), RPab
Galectin-3 (C6C10), MMab
CD5 (C6A10), MMab
GATA3 (L50-823), MMab
Cytokeratin 18 (C6B9), MMab
Cytokeratin 20 (Ks20.8), MMab
HPV 16 (CAMVIR-1), MMab
Vimentin (V9), MMab
p63 (C2C10), MMab
Cytokeratin HMW (34?E12), MMab
Calponin&p63 Cocktail Antibody
Inhibin, alpha (C6H12), MMab
Cytokeratin 8/18 (B22.1 & B23.1), MMab
Cytokeratin 5(C9E33),RMab
Myoglobin (C3H2), MMab
Annexin A1 (C5F8), Mmab
Pax-2 (C9E20), Rmab
Smooth Muscle Myosin (C1X9), RMab
CK17/Ki-67 Reagent
Wilms Tumor (6F-H2), MMab
Factor XIIIa (EP3372), RMab
p57 (KP10), Mmab
Prolactin (EP193), RMab
CDX-2 (C2X5), RMab
INI-1 (MRQ-27), MMab
SALL4 (C2E8), MMab
Parathyroid Hormone(C2G9), MMab
Cytokeratin 7 (C1C10), MMab
CD61 (2f2), MMab
Ki-67 (C3G4), MMab
Cytokeratin 8 (C7E10), MMab
Bcl-6 (C4A4), MMab
Cytokeratin 8/18 (C7E10/C6B9), MMab
CD163 (10D6), MMab
CD1a (C1E1), MMab
LEF-1 (EP310), RMab
Methenamine sliver stain kit
SOX-10 (EP268), RMab
p53/CK20 Cocktail Antibody
HIF-1 (EP118) alpha, RMab
Caldesmon (E89), RMab
Inhibin-? (C6H12), MMab
CD38 (C3G3), MMab
Helicobacter Pylori (polyclonal), RPab
CD61 (MyM1-CD61), MMab
Cytokeratin 8 (C9E18), RMab
OCT2 (MRQ-2), MMab
Cytokeratin 17 (EP98), RMab
Alcian Blue stain kit
Surfactant Protein A (C3F12), MMab
p53 (C2H10), MMab
TTF-1 (C7H7), MMab
Growth Hormone (EP267), RMab
Parathyroid Hormone (MRQ-31), MMab
Microphthalmia Transcription Factor (MiTF)(C5/D5), MMab
Actin, Muscle Specific (C8E11), MMab
Villin (C2E10), MMab
CA125 (OC125), MMab
Myogenin (F5D), MMab
Cytokeratin18 (C6B9), MMab
Glycophorin A, CD235a (JC159), MMab
Oct3/4 (C4E6), MMab
CD56 (C5A2), MMab
MSH2 (G219-1129), MMab
CD138(C5G6), MMab
Estrogen Receptor (C6H7), MMab
Calponin (C6A12), MMab
S100P (C5B10), MMab
Carbonic Anhydrase 9 /(CAIX) (C5C6), MMab
CD30 (C5E10), MMab
CA125 (C6E8), Mmab
Lambda Light Chain (C8A6), MMab
S100P(C5B10),MMab
PAX5/CD3 Cocktail Antibody
CD163 (C2F5), MMab
CK7/Calponin/p63 Cocktail Antibody
TTF-1 (SPT24), MMab
CD45 (2B11&PD7/26), MMab
Calcitonin (C1C2), MMab
GLUT-1 (EP141), RMab
Myeloperoxidase (EP151), RMab
CD15 (MMA), MMab
NapsinA/p40 Cocktail Antibody
CD138 (C5G6), MMab
Myosin Heavy Chain/p63 Cocktail Antibody
Ki-67(C10X1),RMab
MUM1 (C6H9), MMab
CD138/MUM1 Cocktail Antibody
MLH1, MMab
IgM (8H6), MMab
p40(BP6033),RMab
MUC-4 (8G7), Mmab
Glial Fibrillary Acidic Protein (GA5), MMab
MyoD1 (EP212), RMab
Mammaglobin (C7G9), MMab
TFE3 (MRQ-37), RMab
Uroplakin III (EP321), RMab
OCT4 (EP143), Rmab
Thyroglobulin (C6D6), MMab
CD11c (5D11), MMab
Pax-8 (C12A32), MMab
CD10 (C6D1), MMab
CA19-9 (C241:5:1:4), Mmab
FSH (EP257), RMab
Epithelial Specific Antigen/Ep-CAM (Ber-EP4), MMab
PMS2 (EP51), RMab
Lysozyme (polyclonal), RPab
TLE1 (1F5), MMab
Calponin (EP798Y), RMab
MSH2 (C2G3), MMab
MUC6 (MRQ-20), MMab
HHV-8 (13B10), MMab
HMB-45 (C6C9), MMab
Claudin 18.2 (C7X3), RMab
p16/Ki-67 Detection Kit (blue/green)
TdT (C2C8), MMab
CK7/Myosin Heavy Chain/p63 Cocktail Antibody
GCDFP-15 (23A3), MMab
PSAP (C9E30), RMab
SOX-2(EP103),RMab
Fascin (55-K2), MMab
PSA (C2C12), MMab
SATB2/CK20 Cocktail Antibody
Glial Fibrillary Acidic Protein (C2C6), MMab
CDK4 (EP180), RMab
Luteinizing Hormone (polyclonal), RPab
Wilms Tumor (MyR1-WT1), RMab
PNL2(PNL2),MMab
Cyclin D1 (C12A7), RMab
Gastrin (polyclonal), RPab
PGP9.5 (C1G7), MMab
TPO (C3B12), MMab
Napsin A (C2C2), MMab
MUC6 (C8F8),MMab
MSH6 (C5D11), MMab
Melan A (A103), MMab
Melan A(C5G8),MMab
Olig-2 (211F1.1), MMab
Myogenin(MyM1-MYOG), MMab
HER2 (C1F7), MMab
PAX-5 (C2F9), MMab
Androgen Receptor (EP120), PMab
AMACR/p63/CK HMW Cocktail Antibody
BRAF V600E (RM8), RMab
TIA-1 (2G9A10F5), MMab
TLE1 (C3E9), MMab
ROS1, RMab
CD4 (C9E15), RMab
CD30 (polyclonal), RPab
CD20 (C4A11), MMab
ALK (5A4), MMab
Langerin/CD207 (MyM1-CD207), MMab
CD1a (C9E5), RMab
IgA (EP170), RMab
CD99 (EPR3097Y), RMab
EGFR (EP22), Rmab
CD31 (C6E5), MMab
EMA (C12A29), MMab
CK5/6/p40 Cocktail Antibody
c-MYC (EP121), RMab
PD-1 (C5H11), MMab
Mesothelial cell (HBME-1), MMab
CD43 (MT1), MMab
CD99(C1G2),MMab
CD19 (BT51E), MMab
CD2 (C3G8), MMab
INSM1 (BP6240), RMab
Calcitonin (MyM1-CT), MMab
TdT (polyclonal), RPab
p57 (C2G2), MMab
PMS2, MMab
ERG (EP111), RMab
Herpes Simplex Virus I (10A3), MMab
ATRX (BSB-108), MMab
Synaptophysin (C9D11), MMab
TOP2A (C4E3), MMab
E-Cadherin/p120 Cocktail Antibody
CEA (C3G5), MMab
Alpha-1-Fetoprotein (C1B1), MMab
CD3 (C3E7), MMab
Neurofilament (2F11), MMab
STAT6 (EP325), RMab
Hepatocyte (C4F5), MMab
Congo red stain kit
Actin, Muscle Specific Actin (C8E11), MMab
MUC5AC (C1H10), MMab
CA15-3 (DF3), MMab
Glypican 3 (1G12), MMab
HPL (polyclonal), RPab
Cytokeratin 14 (C2D11), MMab
CD66e/CEA (C3G5), MMab
Helicobacter Pylori(SDT-R273), RMab
Reticular fiber stain kit
D2-40 (D2-40), MMab
Progesterone Receptor (C4D10), MMab
IgD (EP173), RMab
CD79a (C4C4), MMab
SOX-10 (C6E11), MMab
p16(C12A24), MMab
PTEN (JRMR-10244-3), RMab
Acid-fast stain kit
Cytokeratin 19 (A53-B/A2.26), MMab
Epithelial Specific Antigen/Ep-CAM (C5C9), MMab
Arginase-1 (EP261), PMab
Bcl-2 (C7B8), MMab
Calretinin (C5G4), MMab
Carbonic Anhydrase 9 /(CAIX)(C5C6), MMab
Galectin-3 (EP412), RMab
Cytokeratin 5&6 (C6H1/C1C8), MMab
Vimentin (C2B4), MMab
CD68 (C2F10), MMab
ALK(C4X1),RMab
HPV (BSB-66(SB 24)), MMab
Human Chorionic Gonadotropin (C5C5), MMab
Smooth Muscle Myosin(C1B2),MMab
Cytokeratin Pan (AE1/AE3), MMab
Annexin A1 (MRQ-3), Mmab
IDH1 (C9E2), MMab
CD2 (AB75), MMab
Trichrome-Masson stain kit
HMB-45 (HMB45), MMab
Epstein-Barr Virus (LMP-1) (CS1/CS2/CS3/CS4Cocktail), MMab
AMACR/p504s (13H4), RMab
Glutamine Synthetase (C6E12), MMab
Collagen Type IV (CIV-22), MMab
Iron stain kit
TTF-1/Napsin A Cocktail Antibody
Stathmin (C12A34), MMab
Granzyme B (EP230), RMab
Synaptophysin (MRQ-40), Rmab
NeuN (A60), MMab
CD34 (QBEnd/10), MMab
DOG1 (C2E3), MMab
CD138 (EP201), RMab
EMA (E29), Mmab
p16 (C4H6), MMab
CD8 (C2B11), MMab
Cytomegalovirus (8B1.2,1G5.2 & 2D4.2), MMab
IgG4 (MRQ-44), MMab
Desmin ( C3B7 ), MMab
MLH1 (C12A19), MMab
CD56(C6E9),MMab
AMACR/p504s(C7H4), MMab
HCG(C5C5), MMab
CD57 (NK-1), MMab
CD23 (C3B11), MMab
CD117(EP10),RMab
CD4/CD8 Cocktail Antibody
NSE (C8E5), MMab
CK5/6&p63 Cocktail Antibody
IMP3 (MyR1-IMP3), RMab
Cytokeratin 7/8 (CAM5.2), MMab
ZAP-70(2F3.2),MMab
MUC-1 (C3C1), MMab
Osteopontin/OPN (OTI5E4), MMab
Brachyury (RBT-TBXT), RMab
TSH (C12A17), MMab
CD44 (MRQ-13), MMab
EGFR (C1E7), MMab
Herpes Simplex Virus II (polyclonal), RPab
p40 (C3B4), MMab
S100 (4C4.9), MMab
Factor VIII (36B11), MMab
pan-CK/Desmin Cocktail Antibody
AMACR/p504s(C12A22),RMab
IgG (polyclonal), Rpab
E-Cadherin (C12A15), Rmab
CD7 (MyR1-CD7), RMab
SATB2 (EP281), RMab
Perforin(MRQ-23),MMab
Pax-5 (C12A5), MMab
Renal Cell Carcinoma Marker (PN-15), MMab
Beta-Catenin (14), MMab
Cytokeratin 19 (C8G9), MMab
FLI-1 (MRQ-1), MMab
p120 (EP66), RMab
Epithelial Specific Antigen/Ep-CAM (MOC-31), MMab
DPC4 (RBT-SMAD4), RMab
Chromogranin A (C1E8), MMab
MDM2 (OTI17B3), MMab
MUC-2 (MRQ-18), MMab
Desmin (D33), MMab
Placental Alkaline Phosphatase (BSB-47), Mmab
CD21 (SC0681), RMab
Cytokeratin14 (C2D11), MMab
Androgen Receptor (C1B4), MMab
MicroStacker™ AP Polymer Detection Kit (Red)
CK5/6/TTF-1 Cocktail Antibody
Prolactin (C8E12), MMab
PRAME (EPR20330), RMab
Cytokeratin 20 (C7C11), MMab
Mucicarmine stain kit
Periodic acid Schiff-PAS stain kit
High Iron Diamine-Alcian Blue (HID-AB) stain kit
AB-PAS stain kit
MicroStacker™ Polymer Detection Kit
DualStacker™ Detection Kit (Dual staining I)
MicroStacker™ Polymer Detection Kit, Universal (3 Components)
Antigen Retrieval Solution (Citrate)
DualStacker™ Detection Kit (Dual staining II)
Antigen Retrieval Solution II
Primary Antibody Diluent
MicroStacker™ Flex Polymer Detection Kit
MicroStacker™ Polymer Detection Kit, Enhanced, 2-Step (5 components)
Dewax Solution
MicroStacker™ Polymer Detection Kit, Universal (5 components)
ICC Dual Stain Detection Kit
Antigen Retrieval Solution (EDTA)
Cell sample Wash Solution
DAB Chromogen Kit
MicroStacker™ Polymer Detection Kit, Enhanced,1-Step
Probe Cleaning Kit
MicroStacker™ Polymer Detection Kit, Enhanced, 2-Step (6 Components)
Kappa&Lambda Chain Dual Stain Kit(ISH)
MicroStacker™ Polymer Detection Kit, Enhanced,1-Step (5 Components)
Frozen Section Fixative
PolyStacker™ anti-Mouse detection kit
Kappa Chain Detection Kit (Instrument)
MicroStacker™ Ultra Polymer Detection Kit
PolyStacker™ anti-Rabbit detection kit
MicroStacker™ Polymer Detection Kit, Enhanced, 2-Step (4 Components)
Cell Preservation Solution
MicroStacker™ Plus Polymer Detection Kit
EBER /CD3 Dual Stain Kit
Antigen Retrieval Solution I
MicroStacker™ Polymer Detection Kit, Universal (4 components)
HPV Test Kit (HPV-HR) (ISH)
Helicobacter pylori stain kit
Cytomegalovirus (CMV) Detection Kit
Washing Solution Concentrate (10X)
Wash Solution 10X Concentrate (TBS)
PBS Wash Solution Powder
Frozen Section Wash Buffer (10X)
Establishment Types
Manufacture Medical Device