PATHNSITU BIOTECHNOLOGIES PVT LTD

FDA Device Registration & Listing · HYDERABAD Telangana, IN · Registration 3014165737

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014165737
FEI Number
3014165737
Entity Name
PATHNSITU BIOTECHNOLOGIES PVT LTD
City/State/Country
HYDERABAD Telangana, IN
Establishment Address
PS Heights Plot#A-28/1/11B/B, Road # 15/2 Nacharam IDA, HYDERABAD Telangana 500076, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PathnSitu Biotechnologies Pvt Ltd (Owner Number: 10056443)
Owner / Operator Contact Address
PLOT NO 10/8, Plot A-28/1/11b/b, Ps Heights 2nd Floor, Road No 15/2, Nacharam, Medchal-Malkajgiri, IN-TG 500076, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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) MASSON’S 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2018-01-03
HYW Stain, Trichrome, Mallory'S Hematology Class 1 864.1850 2025-04-16
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2017-12-22
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2022-03-16
MXT Device, Accessory, Cooling Plate For Tissue Embedding Station Pathology Class 1 864.3010 2025-04-08
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 2018-01-03
IDY Bath, Flotation, Tissue Pathology Class 1 864.3010 2025-04-08

Official Correspondent

No official correspondent registered.

US Agent Details

Marc Key Email: key.marc@gmail.com Phone: (805) 5707214

Related Public Records

Same Entity

PathnSitu Biotechnologies Pvt Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014165737. Last updated year: 2026. Please use registration number 3014165737 when referencing this establishment in official correspondence.
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