FDA Registration
Active
🇮🇳 India
CD23 (EP75)
Reg #: 3014165737
·
FEI: 3014165737
·
Expires 2025
Products
1
Proprietary Names
347
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PATHNSITU BIOTECHNOLOGIES PVT LTD
- Registration Number
- 3014165737
- FEI Number
- 3014165737
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PS Heights Plot#A-28/1/11B/B, Road # 15/2 Nacharam IDA
- City
- HYDERABAD Telangana
- Country
- IN
Owner / Operator
- Firm Name
- PathnSitu Biotechnologies Pvt Ltd
- Operator Number
- 10056443
- Address
- PLOT NO 10/8, Plot A-28/1/11b/b, Ps Heights 2nd Floor, Road No 15/2, Nacharam
- City
- Medchal-Malkajgiri
- State
- Telangana
- Postal Code
- 500076
- Country
- IN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2017-12-22 |
Proprietary Names
CD23 (EP75)
COX2 (EP293)
Actin (1A4)
NSE gamma (ENO2/1462)
PTH (PTH/911)
PAX-8 (EP331)
PR (PRM122)
GFAP (FLIP)
IgG4 (EP138)
MDM2 (D7)
CD5 (EP77)
OCT-4 (EP143)
CD19 (EP169)
PMS2 (MMRP)
CD90 (EP56)
MYOD1 (HLHTP)
PRAME (EP461)
p63 (KETP)
CK8/18 (EP17/EP30)
FOXA1 (EP277)
ALPHA ACTIN (SMOOTH MUSCLE) (EP188)
HSP70 (EP377)
ATRX (D-5)
CD8a (C8/468)
Uroplakin (EP321)
ANNEXIN A1 (BSB-95)
P40 (PRM115)
CD3 (TCRP)
Muscle Actin (HUC1-1)
ATRX (XH2P)
ACE-2 (PDAP)
CK20 (Ks20.8)
CD105 (EP274)
CD57 (NK1)
CD3 (EP41)
DOG 1 (EP332)
PSAP (EP53)
CD56 (PRM123)
CD15 (MMA)
SALL4 (ZPSP)
FOXP3 (EP340)
GRIA-2 (EP387)
MELAN-A (A103)
CK10 (EP97)
AFP (EP209)
MSH2 (PRM112)
TRANSCRIPTION FACTOR PU.1 (EP18)
EP-CAM (MOC31)
P53 (D0-7)
CD4 (TYP)
ZAP70 (SYKP)
AFP (Polyclonal)
ANTI BRAF-V600E (PRM125)
Myogenin (EP162)
CPS1 (EP265)
MCM2 (EP40)
PSAP (PASE/4LJ)
VIMENTIN (V9)
OLIG2 (EP112)
EP-CAM (TMGP)
CYCLIN-D1 (PRM132)
VILLIN (ACBP)
SDHB (PGL4P)
CD3 (Polyclonal)
CK5/14 (EP24/61)
CD45RB (2B11+PD7/26)
CD63 (EP211)
MLH1 (GM011)
Vimentin (EP21)
Topoisomerase-2-? (TI2aP)
PMEL-17 (GP100P)
hCG (PRM131)
CD5 (LEU1P)
CD79a (EP82)
CD38 (EP135)
FSH (EP257)
MYOSIN HEAVY CHAIN (EP166)
Cathepsin -D (EP81)
CK7 (EP16)
PD1 (PDCD1/922)
ANTI P16 INK4A (PRM121)
OCT3/4 (OTFP)
MYOGENIN (RPMDP)
CD79a (MB1P)
LH ALPHA (LHa/756)
ACTH (AH26+57)
LYSOZYME (EP134)
Calcitonin (EP92)
MUM1 (EP190)
BCL-2 (EP36)
NAPSIN A (PRM124)
BOB1/OBF1 (PRM126)
TdT (DNTP)
PR (PGRP)
CD35 (KNP)
MCM6 (EP375)
KAPPA LIGHT CHAIN (EP171)
MSH6 (EP49)
CD8 (EP334)
TRIM29 (TRIM29/1041)
SOX10 (SRYP)
KI-67 (PMPP)
CA125 (M16P)
CA125 (EP48)
LANGERIN (CD207) (EP349)
NEUROFILAMENT (EP79)
BCL-6 (EP278)
KIM-1 (EP309)
NKX2.2 (NX2/294)
PSA (EP109)
CD30 (TRA30P)
P63 (PRM114)
Cytokeratin PAN (EHKP)
CD10 (C6D1)
CD38 (PRM135)
CD163 (EP324)
CD209 (C209/1781)
DESMIN (GM007)
CD138 (EP201)
PGP9.5 (Polyclonal)
SOX-2 (EP103)
Myelin basic protein (EP207)
Synaptophysin (SYPP)
HIF-1 Alpha (EP118)
INHIBIN (R1)
MUC4 (EP256)
CD21 (EP64)
Mammaglobin (EP249)
STAT-6 (EP325)
Nucleophosmin (28M1)
Lambda Light chain (EP172)
Lambda light chain (MCGP)
CK8/18 (IFGFP)
CTLA-4 (GSEP)
MSH2 (RED2)
EP-CAM (BER-EP4)
GROWTH HORMONE (EP267)
ALDH1A1 (EP168)
P40 (delta NPP)
ROS1 (EP282)
CALD1 (PRM134)
HepPar-1 (OCH1E5)
Ki-67 (MIB-1)
MUC2 (EP187)
CD35 (EP197)
GATA-3 (EP368)
CKAE1/AE3 (AE1/AE3)
PAX-5 (EP156)
TPO (THYROID PERIOXIDASE) (PRM127)
CD20 (BCAP)
Podoplanin (T1AP)
PSA (APSP)
C4D (C4D204)
CA19.9 (121SLE)
CD41 (EP178)
CD43 (DF-T1)
Calponin (EP63)
PLAP (EP194)
PD1 (EP239)
Ki67 (PRM113)
CD8a (PRM118)
CD21 (CR2P)
THROMBOMODULIN/CD141 (ZM105)
CD117 (EP10)
MUC5AC (CLH2)
BETACATENIN (EP35)
Serum Amyloid A (EP335)
CD205 (EP176)
SATB2 (PRM111)
PAX 8 (PRM133)
Galectin-3 (B2C10)
MYOSIN LIGHT CHAIN (EP99)
CD31(PECAM-1) (GM006)
GATA-3 (L50-823)
CDX2 (EP25)
GLYCOPHORIN-A (EP213)
TDT (EP266)
FASCIN (SPM133)
CD3 (PS1)
CD138 (SDCP)
TTF1 (HBPP)
MSH6 (GTBP)
Androgen Receptor (EP120)
NKX3.1 (EP356)
Annexin-VII (EP367)
CD103 (EP206)
Neuronal Nuclei (A60)
RRM1 (EP242)
ERG (ETSP)
INSM 1 (IA1P)
CD56 (123C3)
GFAP (EP13)
ARGINASE 1 (ARG1/1125+ARG1/1126)
CD34 (Qbend10)
TTF-1 (EP229)
Prostein-P501S,SLC45A3 (EP381)
Carbonic Anhydrase-9 (EP161)
Chromogranin-A (Polyclonal)
Cyclin-D1 (EP12)
CD7 (EP132)
CD30 (Ber-H2)
HUMAN PLACENTAL LACTOGEN (EP241)
P63 (4A4)
Thyroglobulin (EP250)
GCDFP 15 (EP95)
LI -Cadherin (EP86)
CK8 (IFGP)
WT1 (GUDP)
MUC 1 (PEMP)
CD2 (EP222)
CK20 (EP23)
CD31 (EP78)
MART-1 (EP43)
FACTOR-XIII-A (EP292)
COL1A1 (EP236)
P53 (BP-53-12)
HER2 (PRM116)
BRG-1 (SNFP)
CD99 (MIC2P)
MPO (EP151)
FOXP1 (EP137)
MCM5 (EP84)
PODOPLANIN (D2-40)
S100BETA (EP32)
P16 (JC8)
CYTOKEARTIN 17 (EP98)
CD15 (EP273)
CD95 (EP208)
EMA (E29)
CYCLIN-E1 (EP126)
Clusterin (EP181)
P53 (PRM129)
SATB2 (EP281)
E-CADHERIN (CDCAP)
AMACR (BOFAP)
PAX-8 (PBGP)
LAMININ (Polyclonal)
C-Myc (EP121)
MUC-1 (EP85)
Calretinin (Polyclonal)
PMS2 (EP51)
PD-L1 (B7H1P)
Synaptophysin (EP158)
DOG1 (ANO1P)
CD30 (PRM128)
EGFR (HERP)
CD68 (KP1)
E-Cadherin (EP6)
CD34 (EP88)
CK7 (OVTL12/30)
HLA-DRB1 (EP191)
CD117 (PRM117)
PAX2 (FSGSP)
CD7 (LEU9P)
CEA (COL-1)
HISTONE H3 PHOSPHO(pt3) (EP233)
KERATIN (CAM5.2)
CD45 (EP68)
CD248 (EP383)
MyoD1 (EP212)
MSH3 (PRM119)
Calcitonin (PCTP)
CD23 (FCEP)
TCL-1 (EP105)
Chromogranin-A (EP38)
CK13 (EP69)
CD74 (EP167)
GEMININ (EP355)
PSMA (EP192)
SALL-4 (EP299)
Perforin-1 (PRF1/2470)
HCG-BETA (CGBP)
CD11c (EP157)
CK14 (LL002)
MMP-7 (EP388)
CKHMW (34BE12)
MESOTHELIN (EP140)
PCNA (EP91)
EBV LMP-1 (3H2104,a,b,c)
CYTOKERATIN 14 (NJFP)
MELANOSOME (HMB45)
INI-1 (25)
Glypican-3 (1G12-GPC3/863)
Ki-67 (GM010)
TSH (EP254)
Anti-NeUN (PFOX3)
CD13 (EP117)
Mammaglobin (SGAP)
A-1-ANTI CHYMOTRYPSIN (EP384)
CD20 (L26)
INSULIN (EP125)
TNF-ALPHA (TNF1172)
CD44 (HCAM/918)
HCG (CGP)
Cytokeratin 5&6 (EBS1P)
Cytokeratin(HMW) (K903P)
CD15 (BRA-4F1)
CD117 (Polyclonal)
C4D (EP272)
Caldesmon (EP19)
SOX10 (EP268)
Cytokeratin 18 (EP30)
SOX11 (CL0142)
CDX2 (TSGP)
BRAF (PRM130)
CK5/6 (EP24/EP67)
MDR1 (EP271)
CD1a (EP80)
CD99 (EP8)
Prolactin (EP193)
TLE.1 (1F5)
CD10 (MMEP)
SOX9 (EP317)
Uroplakin III (P35P)
Caldesmon(ZM79)
Top2a (PRM125 )
CD44 (EP44)
CD45RO (UCHL-1)
Myoglobin (EP87)
CD4 (EP204)
Napsin-A (EP205)
OCT-2 (EP284)
GLUT-1 (EP141)
TFE-3 (EP285)
GRANZYME B (EP230)
Somatostatin (SRIP)
Galectin-3 (EP412)
CD10 (NEPP)
ER Alpha (ORAP)
OCT-2 (EP115)
MUC1 (GP1.4+E29)
IMP-3 (EP286)
ERG (EP111)
CEA (EP216)
p120 Catenin (EP66)
CDK4 (EP180)
CK19 (EP72)
COX2 (SP21)
PAX-2 (EP235)
Survivin (EP119)
ZAP70 (PRM120)
Annexin A1 (EP433)
p21 (CIP1P)
Vonwillebrand factor (Polyclonal)
Collagen IV (CO4P)
PAX5 (BCMP)
L1CAM (CD171) (EP411)
Establishment Types
Manufacture Medical Device