LUMATAS BIOSYSTEMS, INC

FDA Device Registration & Listing · Milpitas, CA, US · Registration 3010139432

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
3010139432
FEI Number
3010139432
Entity Name
LUMATAS BIOSYSTEMS, INC
City/State/Country
Milpitas, CA, US
Establishment Address
1870 Milmont Drive, Milpitas, CA 95035, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Lumatas BioSystems, Inc (Owner Number: 10043710)
Owner / Operator Contact Address
1870 Milmont Drive, Milpitas, CA 95035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Lumatas Autostaining System (Model Name: Titan) Lumatas Autostaining System (Model Name: Titan S) DAB Away Kit Titan Prime Universal AP Polymer Detection Kit with Fast Red Phosphate Buffered Saline Titan Prime Universal HRP Polymer Detection Kit with DAB Titan HRP DAB 30 mL Kit Deparaffinization Solution Titan AP Fast Red 30 mL Kit Antigen Retrieval Solution Neutral (50X) Phosphate Buffered Saline with Tween 20 (20X) Hematoxylin Solution Endogenous Peroxidase Blocker Titan Double Stain Kit Antigen Retrieval Solution DNS (50X) Mouse Monoclonal Anti-Human CD163(MX081) Antibody Rabbit Monoclonal Anti-Huamn CD73(MXR014) Antibody Mouse Monoclonal Anti-Human Human Growth Hormone(GH)(MX091) Antibody Mouse Monoclonal Anti-Human Smooth Muscle Actin(MX097) Antibody Rabbit Monoclonal Anti-Huamn CD79a(MXR020) Antibody Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody Mouse Monoclonal Anti-Human MSH2(MX061) Antibody Mouse Monoclonal Anti-Human CD45(MX145) Antibody Mouse Monoclonal Anti-Human Langerin(CD207)(MX121) Antibody Mouse Monoclonal Anti-Human CA 125(MX055) Antibody Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody Mouse Monoclonal Anti-Human MNDA(MX122) Antibody Mouse Monoclonal Anti-Human CD235a, Glycophorin A(MX142) Antibody Mouse Monoclonal Anti-Human LAG3(MX100) Antibody Mouse Monoclonal Anti-Human Bcl-6(MX042) Antibody Mouse Monoclonal Anti-Human Anti-Chromogranin A(MX018) Antibody Rabbit Monoclonal Anti-Huamn Villin(MXR040) Antibody Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody Mouse Monoclonal Anti-Human CD61(MX037) Antibody Mouse Monoclonal Anti-Human HBsAg(MX103) Antibody Mouse Monoclonal Anti-Human T-Pit(MX102) Antibody Mouse Monoclonal Anti-Human CK7(MX053) Antibody Mouse Monoclonal Anti-Human CD43(MX099) Antibody Mouse Monoclonal Anti-Human Caldesmon (MX077) Antibody Mouse Monoclonal Anti-Human CD56(MX039) Antibody Mouse Monoclonal Anti-Human TdT(MX010) Antibody Mouse Monoclonal Anti-Human CK20(MX059) Antibody Rabbit Monoclonal Anti-Huamn AMACR/P504S(MXR012) Antibody Mouse Monoclonal Anti-Human CD99(MX111) Antibody Rabbit Monoclonal Anti-Huamn PD-L1(MXR006) Antibody Mouse Monoclonal Anti-Human WT1(MX012) Antibody Mouse Monoclonal Anti-Human CD3(MX036) Antibody Mouse Monoclonal Anti-Human Stathmin(MX065) Antibody Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody Rabbit Monoclonal Anti-Huamn CD47(MXR005) Antibody Mouse Monoclonal Anti-Human Synaptophysin(MX038) Antibody Mouse Monoclonal Anti-Human CK19(MX054) Antibody Rabbit Monoclonal Anti-Huamn CDX2(MXR024) Antibody Mouse Monoclonal Anti-Human P63(MX013) Antibody Rabbit Monoclonal Anti-Huamn CD23(MXR015) Antibody Rabbit Monoclonal Anti-Huamn S100(MXR034) Antibody Mouse Monoclonal Anti-Human Calponin(MX023) Antibody Mouse Monoclonal Anti-Human CD5(MX052) Antibody Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPO IIa)(MX108) Antibody Mouse Monoclonal Anti-Human CK5/6(MX040) Antibody Rabbit Monoclonal Anti-Huamn CD4(MXR036) Antibody Mouse Monoclonal Anti-Human Napsin A(MX015) Antibody Mouse Monoclonal Anti-Human Podoplanin(MX025) Antibody Mouse Monoclonal Anti-Human MUC5AC(MX126) Antibody Rabbit Monoclonal Anti-Huamn STAT6(MXR031) Antibody Mouse Monoclonal Anti-Human Pax-5(MX017) Antibody Rabbit Monoclonal Anti-Huamn Trop2(TACSTD2)(MXR033) Antibody Mouse Monoclonal Anti-Human CD34(MX123) Antibody Mouse Monoclonal Anti-Human SALL4(MX128) Antibody Mouse Monoclonal Anti-Human HBcAg(MX104) Antibody Mouse Monoclonal Anti-Human MSH6(MX056) Antibody Rabbit Monoclonal Anti-Huamn Carcinoembryonic Antigen(CEA)(MXR058) Antibody Rabbit Monoclonal Anti-Huamn Mammaglobin(MXR049) Antibody Rabbit Monoclonal Anti-Humam CD200(MXR044) Antibody Mouse Monoclonal Anti-Human IDO1(MX085) Antibody Mouse Monoclonal Anti-Human HFN1Beta(MX092) Antibody Rabbit Monoclonal Anti-Huamn Androgen Receptor/AR(MXR023) Antibody Rabbit Monoclonal Anti-Huamn CK8(MXR035) Antibody Mouse Monoclonal Anti-Human P53(MX008) Antibody Rabbit Monoclonal Anti-Huamn CD21(MXR017) Antibody Mouse Monoclonal Anti-Human PSMA(MX095) Antibody Mouse Monoclonal Anti-Human CD10(MX002) Antibody Mouse Monoclonal Anti-Human CD68(MX075) Antibody Mouse Monoclonal Anti-Human HP(MX014) Antibody Mouse Monoclonal Anti-Human Cytokeratin 8(MX004) Antibody Rabbit Monoclonal Anti-Huamn CD7(MXR018) Antibody Mouse Monoclonal Anti-Human CD31(MX032) Antibody Rabbit Monoclonal Anti-Human Ki-67(MXR002) Antibody Mouse Monoclonal Anti-Human P120(MX124) Antibody Rabbit Monoclonal Anti-Huamn Beta-Catenin(MXR022) Antibody Mouse Monoclonal Anti-Human FR Alpha(MX129) Antibody Mouse Monoclonal Anti-Human PLAP(MX112) Antibody Mouse Monoclonal Anti-Human CD30(MX080) Antibody Mouse Monoclonal Anti-Human Ki-67(MX006) Antibody Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody Rabbit Monoclonal Anti-Huamn Pan-TRK(MXR032) Antibody Rabbit Monoclonal Anti-Huamn B7H4(MXR054) Antibody Rabbit Monoclonal Anti-Human C-Met(MXR039) Antibody Rabbit Monoclonal Anti-Huamn PD-L1(MXR025) Antibody Mouse Monoclonal Anti-Human ALK(MX064) Antibody Mouse Monoclonal Anti-Human PD-1(MX033) Antibody Mouse Monoclonal Anti-Human VISTA(MX086) Antibody Rabbit Monoclonal Anti-Huamn BRG1/SMARCA4(MXR028) Antibody Mouse Monoclonal Anti-Human Myogenin(MX078) Antibody Mouse Monoclonal Anti-Human Pit1(MX106) Antibody Mouse Monoclonal Anti-Human MUC-4(MX139) Antibody Rabbit Monoclonal Anti-Huamn SSTR2(MXR041) Antibody Mouse Monoclonal Anti-Human Beta-Catenin(MX043) Antibody Mouse Monoclonal Anti-Human Desmin(MX046) Antibody Mouse Monoclonal Anti-Human Cytokeratin(Pan)(MX005) Antibody Rabbit Monoclonal Anti-Huamn C-ErbB-2(MXR011) Antibody Mouse Monoclonal Anti-Human CD35(MX101) Antibody Mouse Monoclonal Anti-Human Nm23(MX050) Antibody Mouse Monoclonal Anti-Human PRL(MX094) Antibody Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody Mouse Monoclonal Anti-Human Actin (Muscle Specific)(MX083) Antibody Rabbit Monoclonal Anti-Huamn Pax-8(MXR013) Antibody Mouse Monoclonal Anti-Human Vimentin(MX034) Antibody Mouse Monoclonal Anti-Human SDHB(MX096) Antibody Mouse Monoclonal Anti-Human Bcl-2(MX022) Antibody Mouse Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MX068) Antibody Mouse Monoclonal Anti-Human TTF-1(MX011) Antibody Mouse Monoclonal Anti-Human Melanoma(MX026) Antibody Rabbit Monoclonal Anti-Huamn P40(MXR010) Antibody Mouse Monoclonal Anti-Human CD20(MX003) Antibody Mouse Monoclonal Anti-Human PSA(MX030) Antibody Mouse Monoclonal Anti-Human CD19(MX016) Antibody Mouse Monoclonal Anti-Human CD8(MX117) Antibody Mouse Monoclonal Anti-Human IDH-1(MX031) Antibody Mouse Monoclonal Anti-Human GFAP(MX047) Antibody Rabbit Monoclonal Anti-Huamn ALK(MXR016) Antibody Rabbit Monoclonal Anti-Huamn Cytokeratin 5(MXR029) Antibody Rabbit Monoclonal Anti-Huamn Brachyury/Bry.(MXR027) Antibody Mouse Monoclonal Anti-Human DOG1(MX067) Antibody Mouse Monoclonal Anti-Human CK14(MX057) Antibody Rabbit Monoclonal Anti-Huamn Progesterone Receptor(MXR008) Antibody Mouse Monoclonal Anti-Human MUC6(MX110) Antibody Rabbit Monoclonal Anti-Human Cyclin D1(MXR056) Antibody Mouse Monoclonal Anti-Human MDM2(MX133) Antibody Mouse Monoclonal Anti-Human BRAF V600E(MX125) Antibody Mouse Monoclonal Anti-Human E-Cadherin (MX020) Antibody Mouse Monoclonal Anti-Human CK17(MX058) Antibody Mouse Monoclonal Anti-Human ACTH(MX140) Antibody Mouse Monoclonal Anti-Human GCDFP-15(MX120) Antibody Mouse Monoclonal Anti-Human MUM1(MX093) Antibody Mouse Monoclonal Anti-Human EMA(MX132) Antibody Mouse Monoclonal Anti-Human MGMT(MX114) Antibody Rabbit Monoclonal Anti-Huamn SOX10(MXR026) Antibody Mouse Monoclonal Anti-Human MyoD1(MX049) Antibody Mouse Monoclonal Anti-Human Pgp(P-Glycoprotein)(MX079) Antibody Rabbit Monoclonal Anti-Huamn Estrogen Receptor(MXR030) Antibody Mouse Monoclonal Anti-Human MUC2(MX127) Antibody Rabbit Monoclonal Anti-Huamn SOX-11(MXR046) Antibody Mouse Monoclonal Anti-Human BTLA(MX088) Antibody Rabbit Monoclonal Anti-Huamn ERG(MXR004) Antibody Mouse Monoclonal Anti-Human MLH1(MX063) Antibody Mouse Monoclonal Anti-Human CK18(MX035) Antibody Rabbit Monoclonal Anti-Huamn Calcitonin(MXR059) Antibody Mouse Monoclonal Anti-Human Hepatocyte(MX119) Antibody Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody Mouse Monoclonal Anti-Human P16(MX007) Antibody Mouse Monoclonal Anti-Human CD1a(MX115) Antibody Mouse Monoclonal Anti-Human Follicle-Stimulating Hormone(FSH)(MX116) Antibody Rabbit Monoclonal Anti-Huamn PMS2(MXR019) Antibody Mouse Monoclonal Anti-Human CD2(MX074) Antibody Mouse Monoclonal Anti-Human Inhibin Alpha(MX098) Antibody Mouse Monoclonal Anti-Human MPO(MX069) Antibody Rabbit Monoclonal Anti-Huamn B7H3(MXR045) Antibody Mouse Monoclonal Anti-Human CK-HMW (MX134) Antibody Rabbit Monoclonal Anti-Huamn Oligo-2(MX048) Antibody Mouse Monoclonal Anti-Human CD38 (MX044) Antibody Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody Mouse Monoclonal Anti-Human TSH(MX090) Antibody

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2013-03-13
PPM General Purpose Reagent Pathology Class 1 864.4010 2025-12-23
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2023-07-06

Official Correspondent

Delia Yuen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lumatas BioSystems, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3008505743 PATHCOM SYSTEMS CORPORATION Dublin, CA, US
3009596884 DAGATRONICS CORPORATION Goyang Gyeonggi, KR
3005716001 Agilent Technologies LDA Penang Pulau Pinang, MY
3016621374 Jiangsu Medomics Medical Technology Co., Ltd. Nanjing Jiangsu, CN
3016438761 ABBOTT LABORATORIES Irving, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010139432. Last updated year: 2026. Please use registration number 3010139432 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.