FDA Registration
Active
🇮🇳 India
PATHNSITU BIOTECHNOLOGIES PVT LTD
Reg #: 3014165737
·
FEI: 3014165737
·
Expires 2026
Products
12
Proprietary Names
437
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- PATHNSITU BIOTECHNOLOGIES PVT LTD
- Registration Number
- 3014165737
- FEI Number
- 3014165737
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2018-01-03 |
| Stain, Trichrome, Mallory'S | HYW | Class 1 | Hematology | No | 2025-04-16 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2017-12-22 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2022-03-16 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2025-04-08 |
| Hematoxylin Mayer'S | HYL | Class 1 | Hematology | No | 2018-01-03 |
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2025-04-08 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2025-04-08 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2018-01-03 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2018-01-03 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2018-01-03 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2025-04-08 |
Proprietary Names
Grossing Station 7feet (Without height adjustment)
Flexigross Grossing Station 6feet (With height adjustment)
Flexigross Grossing Station 5feet (With height adjustment)
Grossing Station 6feet (Without height adjustment)
Grossing Station 8feet (Without height adjustment)
Flexigross Grossing Station 7feet (With height adjustment)
Grossing Station 4feet (Without height adjustment)
Denaturation & hybridization system
Flexigross Grossing Station 8feet (With height adjustment)
Flexigross Grossing Station 3feet (With height adjustment)
Grossing Station 5feet (Without height adjustment)
Grossing Station 3feet (Without height adjustment)
Flexigross Grossing Station 4feet (With height adjustment)
Flexigross Grossing Station 9feet (With height adjustment)
MERS - Pressure Based Antigen Retrieval System
Grossing Station 9feet (Without height adjustment)
MASSONS TRICHROME-NA STAIN
Masson Trichrome
IgG4 (EP138)
CD63 (EP211)
CD5 (EP77)
SALL-4 (EP299)
E-CADHERIN (CDCAP)
PAX2 (FSGSP)
Top2a (PRM125 )
CD68 (KP1)
CD31 (EP78)
CD34 (EP88)
CK7 (OVTL12/30)
SATB2 (EP281)
NAPSIN A (PRM124)
DOG1 (ANO1P)
Galectin-3 (EP412)
MMP-7 (EP388)
A-1-ANTI CHYMOTRYPSIN (EP384)
CKHMW (34BE12)
INSULIN (EP125)
P53 (BP-53-12)
Prolactin (EP193)
SOX10 (SRYP)
CDX2 (TSGP)
TdT (DNTP)
CD23 (EP75)
ALPHA ACTIN (SMOOTH MUSCLE) (EP188)
Actin (1A4)
CD8a (C8/468)
HER2 (PRM116)
Uroplakin III (P35P)
Cytokeratin(HMW) (K903P)
CD31(PECAM-1) (GM006)
GATA-3 (L50-823)
GLYCOPHORIN-A (EP213)
CD35 (EP197)
TTF-1 (EP229)
Uroplakin (EP321)
P63 (PRM114)
Cytokeratin PAN (EHKP)
CD10 (C6D1)
ACTH (AH26+57)
CD117 (Polyclonal)
Caldesmon (EP19)
MUM1 (EP190)
S100BETA (EP32)
TFE-3 (EP285)
EP-CAM (TMGP)
CYCLIN-D1 (PRM132)
VILLIN (ACBP)
Chromogranin-A (Polyclonal)
Cyclin-D1 (EP12)
CD21 (EP64)
CD105 (EP274)
HUMAN PLACENTAL LACTOGEN (EP241)
DOG 1 (EP332)
PAX-2 (EP235)
CD205 (EP176)
SATB2 (PRM111)
HIF-1 Alpha (EP118)
CD23 (FCEP)
TCL-1 (EP105)
CD15 (EP273)
MYOSIN LIGHT CHAIN (EP99)
EMA (E29)
CYCLIN-E1 (EP126)
CDX2 (EP25)
HLA-DRB1 (EP191)
PAX-5 (EP156)
GRANZYME B (EP230)
CD13 (EP117)
Mammaglobin (SGAP)
EGFR (HERP)
CD7 (EP132)
KAPPA LIGHT CHAIN (EP171)
CD8 (EP334)
ERG (EP111)
CD209 (C209/1781)
HISTONE H3 PHOSPHO(pt3) (EP233)
CD138 (EP201)
PLAP (EP194)
Prostein-P501S,SLC45A3 (EP381)
PR (PRM122)
PMEL-17 (GP100P)
ATRX (XH2P)
ACE-2 (PDAP)
SOX10 (EP268)
Myelin basic protein (EP207)
CD8a (PRM118)
ZAP70 (SYKP)
CD21 (CR2P)
Chromogranin-A (EP38)
CD45RB (2B11+PD7/26)
MDM2 (D7)
GEMININ (EP355)
OCT-4 (EP143)
CD19 (EP169)
CD10 (MMEP)
SOX9 (EP317)
AMACR (BOFAP)
CD7 (LEU9P)
PAX-8 (PBGP)
CD79a (EP82)
CD117 (EP10)
FSH (EP257)
BETACATENIN (EP35)
CK7 (EP16)
PGP9.5 (Polyclonal)
CD3 (PS1)
Carbonic Anhydrase-9 (EP161)
CD3 (TCRP)
PSA (APSP)
LAMININ (Polyclonal)
Myoglobin (EP87)
MUC-1 (EP85)
Synaptophysin (EP158)
CD56 (PRM123)
LI -Cadherin (EP86)
CD15 (MMA)
CTLA-4 (GSEP)
MUC 1 (PEMP)
MCM6 (EP375)
CD30 (Ber-H2)
MSH6 (EP49)
Survivin (EP119)
MSH3 (PRM119)
Ki67 (PRM113)
P53 (D0-7)
CD4 (TYP)
CK20 (Ks20.8)
Annexin-VII (EP367)
CD57 (NK1)
CD3 (EP41)
Thyroglobulin (EP250)
Synaptophysin (SYPP)
Galectin-3 (B2C10)
CD163 (EP324)
FOXP3 (EP340)
KERATIN (CAM5.2)
DESMIN (GM007)
CK10 (EP97)
AFP (EP209)
MyoD1 (EP212)
PD1 (EP239)
ANNEXIN A1 (BSB-95)
hCG (PRM131)
GFAP (FLIP)
LH ALPHA (LHa/756)
CD44 (EP44)
CD45RO (UCHL-1)
Calcitonin (EP92)
FOXP1 (EP137)
Napsin-A (EP205)
OCT-2 (EP284)
PD-L1 (B7H1P)
TSH (EP254)
OLIG2 (EP112)
CK8/18 (IFGFP)
INSM 1 (IA1P)
CD2 (EP222)
CD20 (L26)
MESOTHELIN (EP140)
MART-1 (EP43)
FACTOR-XIII-A (EP292)
TLE.1 (1F5)
Cytokeratin 18 (EP30)
BOB1/OBF1 (PRM126)
BRAF (PRM130)
CD38 (EP135)
EP-CAM (BER-EP4)
ALDH1A1 (EP168)
Cathepsin -D (EP81)
Serum Amyloid A (EP335)
FASCIN (SPM133)
CD20 (BCAP)
MSH6 (GTBP)
Podoplanin (T1AP)
HepPar-1 (OCH1E5)
CK8/18 (EP17/EP30)
FOXA1 (EP277)
GFAP (EP13)
ARGINASE 1 (ARG1/1125+ARG1/1126)
ATRX (D-5)
PAX-8 (EP331)
Vimentin (EP21)
Cytokeratin 5&6 (EBS1P)
BRG-1 (SNFP)
CYTOKERATIN 14 (NJFP)
C4D (C4D204)
GRIA-2 (EP387)
MELAN-A (A103)
CD43 (DF-T1)
Vonwillebrand factor (Polyclonal)
VIMENTIN (V9)
MYOD1 (HLHTP)
PRAME (EP461)
CD5 (LEU1P)
CD11c (EP157)
CEA (COL-1)
MUC5AC (CLH2)
MYOSIN HEAVY CHAIN (EP166)
CD45 (EP68)
CD248 (EP383)
SOX-2 (EP103)
TRANSCRIPTION FACTOR PU.1 (EP18)
TPO (THYROID PERIOXIDASE) (PRM127)
P40 (PRM115)
Muscle Actin (HUC1-1)
MPO (EP151)
LYSOZYME (EP134)
MCM5 (EP84)
BCL-2 (EP36)
PMS2 (EP51)
Collagen IV (CO4P)
ERG (ETSP)
Lambda light chain (MCGP)
SDHB (PGL4P)
CK13 (EP69)
MSH2 (RED2)
CD74 (EP167)
GROWTH HORMONE (EP267)
PD1 (PDCD1/922)
CD117 (PRM117)
CD138 (SDCP)
TTF1 (HBPP)
INI-1 (25)
CA125 (EP48)
Glypican-3 (1G12-GPC3/863)
BCL-6 (EP278)
PCNA (EP91)
TNF-ALPHA (TNF1172)
KI-67 (PMPP)
WT1 (GUDP)
CDK4 (EP180)
AFP (Polyclonal)
CK19 (EP72)
COX2 (SP21)
CPS1 (EP265)
RRM1 (EP242)
STAT-6 (EP325)
ROS1 (EP282)
MYOGENIN (RPMDP)
OCT-2 (EP115)
CD15 (BRA-4F1)
MUC1 (GP1.4+E29)
IMP-3 (EP286)
C4D (EP272)
CEA (EP216)
PODOPLANIN (D2-40)
EP-CAM (MOC31)
PAX5 (BCMP)
L1CAM (CD171) (EP411)
THROMBOMODULIN/CD141 (ZM105)
INHIBIN (R1)
MUC4 (EP256)
NKX3.1 (EP356)
Mammaglobin (EP249)
Neuronal Nuclei (A60)
PSAP (EP53)
P63 (4A4)
PAX 8 (PRM133)
Calcitonin (PCTP)
CD79a (MB1P)
MELANOSOME (HMB45)
CD4 (EP204)
C-Myc (EP121)
Ki-67 (GM010)
GLUT-1 (EP141)
Calretinin (Polyclonal)
PSA (EP109)
Nucleophosmin (28M1)
Lambda Light chain (EP172)
CK8 (IFGP)
SALL4 (ZPSP)
CK5/6 (EP24/EP67)
MDR1 (EP271)
CK20 (EP23)
CD99 (EP8)
COL1A1 (EP236)
P53 (PRM129)
SOX11 (CL0142)
CYTOKEARTIN 17 (EP98)
Somatostatin (SRIP)
PR (PGRP)
CD35 (KNP)
CD56 (123C3)
Ki-67 (MIB-1)
MUC2 (EP187)
CD34 (Qbend10)
GATA-3 (EP368)
PTH (PTH/911)
Anti-NeUN (PFOX3)
CD30 (TRA30P)
EBV LMP-1 (3H2104,a,b,c)
CD38 (PRM135)
p120 Catenin (EP66)
CA19.9 (121SLE)
CD41 (EP178)
MSH2 (PRM112)
Calponin (EP63)
PSAP (PASE/4LJ)
Topoisomerase-2-? (TI2aP)
CD90 (EP56)
HCG-BETA (CGBP)
p63 (KETP)
CD95 (EP208)
CD1a (EP80)
E-Cadherin (EP6)
Clusterin (EP181)
CKAE1/AE3 (AE1/AE3)
TDT (EP266)
P16 (JC8)
CD30 (PRM128)
CD10 (NEPP)
ER Alpha (ORAP)
CD3 (Polyclonal)
CK5/14 (EP24/61)
HSP70 (EP377)
COX2 (EP293)
MLH1 (GM011)
NSE gamma (ENO2/1462)
PMS2 (MMRP)
PSMA (EP192)
CD44 (HCAM/918)
HCG (CGP)
Caldesmon(ZM79)
CD99 (MIC2P)
Androgen Receptor (EP120)
ANTI BRAF-V600E (PRM125)
Myogenin (EP162)
CD103 (EP206)
MCM2 (EP40)
Perforin-1 (PRF1/2470)
P40 (delta NPP)
ANTI P16 INK4A (PRM121)
OCT3/4 (OTFP)
CALD1 (PRM134)
CK14 (LL002)
LANGERIN (CD207) (EP349)
NEUROFILAMENT (EP79)
KIM-1 (EP309)
NKX2.2 (NX2/294)
GCDFP 15 (EP95)
TRIM29 (TRIM29/1041)
ZAP70 (PRM120)
Annexin A1 (EP433)
CA125 (M16P)
p21 (CIP1P)
Fully automated IHC stainer - Caliber30
ChromePath
Thermal Console
Cryo Console
Embedding Center
Modified mayer's hematoxylin
Mayer's Hematoxylin
Harries Hematoxylin
Tissue Flotation Bath
Slide Warming Table
Manual Microtome
Fully Automated Microtome
Semi Automated Microtome
GMS STAIN KIT
StunDAB Buffer
Protein Block
Primary Antibody Diluent
Bluing Solution
AFB STAIN KIT
Vonkossa Stain
IM Wash Buffer
Perls Prussion Stain
Alcian Blue Kit
Periodic Acid Schiff (PAS)
Tris-EDTA
Solvent Resistant Marker
PAP STAIN KIT (MODIFIED MAYER'S)
WARTHIN STARRY STAIN KIT
Verhoeff-Vangieson Stain-NA
EDTA Buffer
Polyexcel HRP/DAB Detection System - One step
CONGO RED KIT
10X PBS Solution
Verhoeff-Vangieson Stain
Jones Methanamine Silver
PAP-NA (Papanicolaou) Stain
MUCICARMINE STAIN KIT
Congo Red Stain Kit
Alcian Blue-PAS (ABPAS)
Melanin Bleach
Oil-Red-O Stain Kit
Polyexcel HRP/DAB Detection System- Two step
Masson Fontana Stain
AFB-NA STAIN
Toluidine blue
Reticulin Stain KIT
PAS-Diastase Kit
3 % HYDROGEN PEROXIDE
PAP STAIN KIT ( HARRIS HEMATOXYLIN)
Citrate Buffer
Eosin Solution
Microscope Slide - Cover Glass (100 Pack)
Positively charged slides (Hydrophilic)
Coloured Microscope Slides (Green, Pink, Blue)
Positively Charged Slides (Hydrophobic)
Microscope Slides Plain (72 Slides/Box)
Single Frosted Microscope Slides
Double Frosted Microscope Slides
HER2 (NGLP)
IDH1 (IDH1/1152)
H.PYLORI (Polyclonal)
ALK (1A4)
H.PYLORI (EP279)
ER (EP1)
AMACR (13H4)
ALK (EP302)
PR (EP2)
EGFR (EP22)
Her2/Ber2 (EP3)
Vacuum Tissue Processor (200+ cassettes)
Vacuum Tissue Processor (100+ cassettes)
Vacuum Tissue Processor (300 cassettes)
Establishment Types
Manufacture Medical Device