FDA Registration
Active
🇨🇳 China
PTPRZ1/C-MET Fusion probe
Reg #: 3030509363
·
FEI: 3030509363
·
Expires 2025
Products
1
Proprietary Names
121
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FUZHOU MAIXIN BIOTECH CO., LTD.
- Registration Number
- 3030509363
- FEI Number
- 3030509363
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 98, Chaipai Road, Shangjie Town, Minhou County
- City
- Fuzhou City Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Fuzhou Maixin Biotech Co., Ltd.
- Operator Number
- 10089536
- Address
- No. 98, Chaipai Road, Shangjie Town, Minhou County
- City
- Fuzhou City
- State
- Fujian
- Postal Code
- 350108
- Country
- CN
- Correspondent
- Yanhua Zheng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-03-14 |
Proprietary Names
PTPRZ1/C-MET Fusion probe
CSF1 Dual Color Break Apart Probe
ERG Dual Color Break Apart Probe
C11ORF95/RELA Fusion probe
SMARCB1/EWSR1 Dual Color Probe
CREB1/EWSR1 Dual Color Dual Fusion probe
FOSB Dual Color Break Apart Probe
EWSR1/FLI1 Dual Color Dual Fusion probe
TLX1 Dual Color Break Apart Probe
PD-L2/CSP9 Dual Color Probe
DDIT3/CSP12 Dual Color Probe
11q22.2 Orange Probe
PPAR? Dual Color Break Apart Probe
ABL2 Dual Color Break Apart Probe
MALAT1 Dual Color Break Apart Probe
Wash buffer(For Cell Section)
YWHAE Dual Color Break Apart Probe
FOXO1 Dual Color Break Apart Probe
CCND2 Dual Color Break Apart Probe
NR4A3 Dual Color Break Apart Probe
TP63 Dual Color Break Apart Probe
DAPI Staining Solution
SRD/CSP1 Dual Color Probe
PAX5/IGH Dual Color Dual Fusion probe
TRA/TRD Dual Color Break Apart Probe
BCL6 Dual Color Break Apart Probe
FOS Dual Color Break Apart Probe
BCL2 Dual Color Break Apart Probe
MLAA-34/13q34 Dual Color Probe
NTRK2 Dual Color Break Apart Probe
EWSR1/ATF1 Dual Color Dual Fusion probe
20q11 Green Probe
NCOA3 Dual Color Break Apart Probe
STAT6/CSP12 Dual Color Probe
NUT Dual Color Break Apart Probe
1q21 Orange Probe
i(17q) Dual Color Probe
CIC Dual Color Break Apart Probe
JAZF1 Dual Color Break Apart Probe
RAD21/CSP8 Dual Color Probe
NONO/TFE3 Dual Color Dual Fusion probe
NTRK3 Dual Color Break Apart Probe
KMT2A/CSP11 Dual Color Probe
CSP8 Green Probe
PRCC/TFE3 Dual Color Dual Fusion probe
CSP17 Green Probe
GLI1 Dual Color Break Apart Probe
HMGA2 Dual Color Break Apart Probe
C11ORF95 Dual Color Break Apart Probe
PRKACA Dual Color Break Apart Probe
PDGFB Dual Color Break Apart Probe
Fixation Solution
Sample Release Agent
ABL1 Dual Color Break Apart Probe
MEF2D Dual Color Break Apart Probe
FGFR2 Dual Color Break Apart Probe
MGEA5 Dual Color Break Apart Probe
PD-L1 Dual Color Break Apart Probe
FRS2/CSP12 Dual Color Probe
19p13.3/19q13 Dual Color Probe
D13S319 Orange Probe
RB1/1q21 Dual Color Probe
CTNNB1/CSP3 Dual Color Probe
BCOR Dual Color Break Apart Probe
Epstein-Barr Virus (EBER) Probe(in situ hybridization)
PAX3 Dual Color Break Apart Probe
CDK6/CSP7 Dual Color Probe
CHD1/TERT Dual Color Probe
ALK/CSP2 Dual Color Probe
2p Orange Probe
D11S1037/CSP11 Dual Color Probe
BRAF Dual Color Break Apart Probe
TERC/CSP3 Dual Color Probe
PRDM10 Dual Color Break Apart Probe
SOX2/CSP3 Dual Color Probe
MYC Dual Color Break Apart Probe
MLLT4/CSP6 Dual Color Probe
D13S25 Orange Probe
USP6 Dual Color Break Apart Probe
C19MC/19p13 Dual Color Probe
EBER(Epstein-Barr Virus RNA) Probe kit
TNFAIP3/CSP6 Dual Color Probe
CRTC1 Dual Color Break Apart Probe
5q33.3 Dual Color Probe
MN1 Dual Color Break Apart Probe
ESR1/CSP6 Dual Color Probe
1q Orange Probe
11q23.3/11q24.3 Dual Color Probe
CDH1/CSP16 Dual Color Probe
Buffer solution
NFIB Dual Color Break Apart Probe
P16(CDKN2A)/CSP9 Dual Color Probe
TOP2A/CSP17 Dual Color Probe
RB1/ATM Dual Color Probe
WT1 Dual Color Break Apart Probe
NUP98 Dual Color Break Apart Probe
EPOR Dual Color Break Apart Probe
Pepsin Solution(For cell sample)
EP400 Dual Color Break Apart Probe
TFEB Dual Color Break Apart Probe
IRF4 Dual Color Break Apart Probe
ETV4 Dual Color Break Apart Probe
CSF1R Dual Color Break Apart Probe
PLAG1 Dual Color Break Apart Probe
NCOA2 Dual Color Break Apart Probe
MYB Dual Color Break Apart Probe
CSP7 Green Probe
ZNF384 Dual Color Break Apart Probe
FOXR2 Dual Color Break Apart Probe
CAMTA1 Dual Color Break Apart Probe
BEND2 Dual Color Break Apart Probe
MYC/CSP8 Dual Color Probe
MAML2 Dual Color Break Apart Probe
Pepsin Solution(For tissue section)
CSP11 Green Probe
RELA Dual Color Break Apart Probe
ETV6/NTRK3 Dual Color Dual Fusion probe
COL1A1/PDGFB Dual Color Dual Fusion probe
Twist/CSP7 Dual Color Probe
hWAPL/CSP10 Dual Color Probe
Wash buffer(For Tissue Section)
Establishment Types
Manufacture Medical Device