FDA Registration
Active
🇨🇳 China
Elastic fiber stain kit
Reg #: 3015614371
·
FEI: 3015614371
·
Expires 2025
Products
1
Proprietary Names
279
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CELNOVTE BIOTECHNOLOGY CO., LTD
- Registration Number
- 3015614371
- FEI Number
- 3015614371
- Status
- Active
- Expiry Year
- 2025
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2024-04-02 |
Proprietary Names
Elastic fiber stain kit
Myosin, Smooth Muscle(C1B2), Mmab
MUM1 (C6H9), MMab
CD38 (C3G3), MMab
CK7/Calponin/p63 Cocktail Antibody
Cytokeratin 8 (C7E10), MMab
Human Chorionic Gonadotropin (C5C5), MMab
CD56 (C5A2), MMab
MSH6 (C5D11), MMab
Prolactin (C8E12), MMab
MUC5AC (C1H10), MMab
Claudin 18.2 (C7X3), RMab
Thyroglobulin (C6D6), MMab
Glutamine Synthetase (C6E12), MMab
CK5/6/p40 Cocktail Antibody
Annexin A1 (C5F8), Mmab
pan-CK/p63 Cocktail Antibody
PD-L1 (C9C9), MMab
Glial Fibrillary Acidic Protein (C2C6), MMab
Trichrome-Masson stain kit
CD31 (C6E5), MMab
Cytokeratin 7 (C1C10), MMab
Parathyroid Hormone(C2G9), MMab
PD-1 (C5H11), MMab
CDX-2 (C2X5), RMab
CD123 (6H6), MMab
Langerin/CD207 (MyM1-CD207), MMab
Neurofilament (2F11), MMab
CD34 (QBEnd/10), MMab
ALK (5A4), MMab
CD45RO (UCHL1), MMab
HPL (polyclonal), RPab
Carbonic Anhydrase 9 /(CAIX)(C5C6), MMab
c-MYC (EP121), RMab
TLE1 (1F5), MMab
BRAF V600E (RM8), RMab
CD15 (MMA), MMab
Cytokeratin HMW (34?E12), MMab
Hepatocyte (C4F5), MMab
Pax-8 (C12A32), MMab
TdT (C2C8), MMab
CA19-9 (C241:5:1:4), Mmab
Acid-fast stain kit
IgD (EP173), RMab
Cytokeratin 17 (EP98), RMab
Synaptophysin (MRQ-40), Rmab
Gastrin (polyclonal), RPab
CD138 (C5G6), MMab
Renal Cell Carcinoma Marker (PN-15), MMab
SOX-10 (EP268), RMab
Annexin A1 (MRQ-3), Mmab
SATB2 (EP281), RMab
CD117(EP10), RMab
Reticular fiber stain kit
Alcian Blue stain kit
CD1a (C9E5), RMab
CA15-3 (DF3), MMab
HPV (BSB-66(SB 24)), MMab
ZAP-70(2F3.2),MMab
Pax-5 (C12A5), MMab
Placental Alkaline Phosphatase (BSB-47), Mmab
TTF-1 (SPT24), MMab
Cyclin D1 (C12A7), RMab
CD2 (AB75), MMab
S100 (4C4.9), MMab
Brachyury (RBT-TBXT), RMab
HMB-45 (HMB45), MMab
Cytomegalovirus (8B1.2,1G5.2 & 2D4.2), MMab
Cytokeratin Pan (AE1/AE3), MMab
MUC6 (MRQ-20), MMab
Cytokeratin 5(C9E33), RMab
Cytokeratin 8 (C9E18), RMab
Calponin (EP798Y), RMab
Glycophorin A, CD235a (JC159), MMab
TFE3 (MRQ-37), RMab
MUC-2 (MRQ-18), MMab
ACTH (Polyclonal), RPab
Lysozyme (polyclonal), RPab
Glial Fibrillary Acidic Protein (GA5), MMab
MLH1 (C12A19), MMab
Uroplakin III (EP321), RMab
D2-40 (D2-40), MMab
Epstein-Barr Virus (LMP-1) (CS1/CS2/CS3/CS4Cocktail), MMab
ERG (EP111), RMab
MDM2 (OTI17B3), MMab
CD163 (10D6), MMab
Osteopontin/OPN (OTI5E4), MMab
IgG (polyclonal), Rpab
Cytokeratin 7/8 (CAM5.2), MMab
Stathmin (C12A34), MMab
CD43 (MT1), MMab
MyoD1 (EP212), RMab
CD7 (MyR1-CD7), RMab
CD4 (C9E15), RMab
Arginase-1 (EP261), PMab
Androgen Receptor (EP120), PMab
Myeloperoxidase (EP151), RMab
IgM (8H6), MMab
SOX-2(EP103),RMab
CD138 (EP201), RMab
ATRX (BSB-108), MMab
Collagen Type IV (CIV-22), MMab
LEF-1 (EP310), RMab
Fascin (55-K2), MMab
Granzyme B (EP230), RMab
PSAP (C9E30), RMab
Cytokeratin 19 (A53-B/A2.26), MMab
FLI-1 (MRQ-1), MMab
Prolactin (EP193), RMab
IgG4 (MRQ-44), MMab
Parathyroid Hormone (MRQ-31), MMab
Beta-Catenin (14), MMab
CD57 (NK-1), MMab
CD99 (EPR3097Y), RMab
Cytokeratin 14 (C2D11), MMab
Epithelial Specific Antigen/Ep-CAM (Ber-EP4), MMab
Factor XIIIa (EP3372), RMab
Pax-2 (C9E20), Rmab
S100P(C5B10),MMab
Hepatocyte Specific Antigen (HSA) (C4F5 ), MMab
CD66e/CEA (C3G5), MMab
CD138/MUM1 Cocktail Antibody
Calponin (C6A12), MMab
DOG1 (C2E3), MMab
PAX-5 (C2F9), MMab
p40 (C3B4), MMab
CD4/CD8 Cocktail Antibody
SALL4 (C2E8), MMab
CD20 (C4A11), MMab
p16 (C4H6), MMab
Estrogen Receptor (C6H7), MMab
CK7/Myosin Heavy Chain/p63 Cocktail Antibody
p63 (C2C10), MMab
Synaptophysin (C9D11), MMab
Androgen Receptor (C1B4), MMab
CD163 (C2F5), MMab
Myosin Heavy Chain/p63 Cocktail Antibody
Calponin&p63 Cocktail Antibody
CA125 (C6E8), Mmab
pan-CK/Desmin Cocktail Antibody
TTF-1 (C7H7), MMab
CK5/6&p63 Cocktail Antibody
HMB-45 (C6C9), MMab
Cytokeratin 5&6 (C6H1/C1C8), MMab
p53/CK20 Cocktail Antibody
HER2 (C1F7), MMab
CD2 (C3G8), MMab
TPO (C3B12), MMab
p53 (C2H10), MMab
Cytokeratin 19 (C8G9), MMab
MSH2 (C2G3), MMab
Calcitonin (C1C2), MMab
CD10 (C6D1), MMab
Cytokeratin 20 (C7C11), MMab
Kappa Light Chain (C8H10), MMab
CD8 (C2B11), MMab
Alpha-1-Fetoprotein (C1B1), MMab
SMA (C1C1), MMab
Bcl-2 (C7B8), MMab
Surfactant Protein A (C3F12), MMab
CD23 (C3B11), MMab
MUC-1 (C3C1), MMab
p57 (C2G2), MMab
Mammaglobin (C7G9), MMab
SOX-10 (C6E11), MMab
Lambda Light Chain (C8A6), MMab
EGFR (C1E7), MMab
Methenamine sliver stain kit
SATB2/CK20 Cocktail Antibody
Desmin ( C3B7 ), MMab
NSE (C8E5), MMab
Iron stain kit
Chromogranin A (C1E8), MMab
TTF-1/Napsin A Cocktail Antibody
Carbonic Anhydrase 9 /(CAIX) (C5C6), MMab
Napsin A (C2C2), MMab
Terminal Deoxynucleotidyl Transferase (TdT) (C2C8), MMab
CD138(C5G6), MMab
TLE1 (C3E9), MMab
S100P (C5B10), MMab
PAX5/CD3 Cocktail Antibody
Ki-67 (C3G4), MMab
NapsinA&p40 Cocktail Antibody
Myoglobin (C3H2), MMab
TOP2A (C4E3), MMab
Bcl-6 (C4A4), MMab
CD68 (C2F10), MMab
CD3 (C3E7), MMab
PSA (C2C12), MMab
Cytokeratin 8/18 (C7E10/C6B9), MMab
Cytokeratin18 (C6B9), MMab
OCT4 (EP143), Rmab
CD45 (2B11&PD7/26), MMab
CD19 (BT51E), MMab
Luteinizing Hormone (polyclonal), RPab
STAT6 (EP325), RMab
PMS2 (EP51), RMab
Mesothelial cell (HBME-1), MMab
EGFR (EP22), Rmab
INSM1 (BP6240), RMab
MSH2 (G219-1129), MMab
HCG(C5C5), MMab
E-Cadherin (C12A15), Rmab
IMP3 (MyR1-IMP3), RMab
Olig-2 (211F1.1), MMab
Helicobacter Pylori (polyclonal), RPab
Wilms Tumor (6F-H2), MMab
PNL2(PNL2),MMab
PTEN (JRMR-10244-3), RMab
PGP9.5 (C1G7), MMab
p57 (KP10), Mmab
DPC4 (RBT-SMAD4), RMab
NeuN (A60), MMab
PRAME (EPR20330), RMab
CD11c (5D11), MMab
Myogenin (F5D), MMab
CDK4 (EP180), RMab
Desmin (D33), MMab
p120 (EP66), RMab
Melan A (A103), MMab
Caldesmon (E89), RMab
MUC-4 (8G7), Mmab
GLUT-1 (EP141), RMab
TIA-1 (2G9A10F5), MMab
Vimentin (V9), MMab
CD44 (MRQ-13), MMab
Herpes Simplex Virus I (10A3), MMab
HPV 16 (CAMVIR-1), MMab
CD61 (2f2), MMab
AMACR/p504s (C7H4), MMab
CD1a (C1E1), MMab
AMACR/p63/CK HMW Cocktail Antibody
Vimentin (C2B4), MMab
TSH (C12A17), MMab
IgA (EP170), RMab
Glypican 3 (1G12), MMab
Calcitonin (MyM1-CT), MMab
Microphthalmia Transcription Factor (MiTF)(C5/D5), MMab
PMS2, MMab
EMA (E29), Mmab
OCT2 (MRQ-2), MMab
INI-1 (MRQ-27), MMab
Growth Hormone (EP267), RMab
CD30 (polyclonal), RPab
TdT (polyclonal), RPab
Epithelial Specific Antigen/Ep-CAM (MOC-31), MMab
GCDFP-15 (23A3), MMab
FSH (EP257), RMab
CD21 (SC0681), RMab
GATA3 (L50-823), MMab
HHV-8 (13B10), MMab
Calretinin (C5G4), MMab
E-Cadherin/p120 Cocktail Antibody
Cytokeratin14 (C2D11), MMab
CD30 (C5E10), MMab
CK5/6/TTF-1 Cocktail Antibody
Galectin-3 (C6C10), MMab
CD5 (C6A10), MMab
Congo red stain kit
Inhibin, alpha (C6H12), MMab
Cytokeratin 8/18 (B22.1 & B23.1), MMab
HIF-1 (EP118) alpha, RMab
Cytokeratin 20 (Ks20.8), MMab
Factor VIII (36B11), MMab
Oct3/4 (C4E6), MMab
CD79a (C4C4), MMab
Actin, Muscle Specific Actin (C8E11), MMab
CEA (C3G5), MMab
Cytokeratin 18 (C6B9), MMab
Herpes Simplex Virus II (polyclonal), RPab
Galectin-3 (EP412), RMab
CA125 (OC125), MMab
IDH1 (C9E2), MMab
NKX3.1 (MyR1-NKX3.1), RMab
Perforin(MRQ-23), MMab
Progesterone Receptor (C4D10), MMab
Villin (C2E10), MMab
Inhibin-? (C6H12), MMab
Smooth Muscle Myosin (C1X9), RMab
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device