FDA Registration
Active
🇺🇸 United States
LUMATAS BIOSYSTEMS, INC
Reg #: 3010139432
·
FEI: 3010139432
·
Expires 2026
Products
4
Proprietary Names
213
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- LUMATAS BIOSYSTEMS, INC
- Registration Number
- 3010139432
- FEI Number
- 3010139432
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1870 Milmont Drive
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
Owner / Operator
- Firm Name
- Lumatas BioSystems, Inc
- Operator Number
- 10043710
- Address
- 1870 Milmont Drive
- City
- Milpitas
- State
- CA
- Postal Code
- 95035
- Country
- US
- Correspondent
- Delia Yuen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2013-03-13 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-12-23 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2023-07-06 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2025-06-12 |
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
goldFISH DF330 CHOP Dual Color Break Apart Probe
goldFISH DF008 MYC Dual Color Break Apart Probe
goldFISH DF156 CTNNB1/CSP3 Dual Color Probe
goldFISH DF067 CDKN2A/CSP9 Dual Color Probe
goldFISH DF206 MAF/IGH Dual Color Dual Fusion Probe
goldFISH DF036 BCL2/IGH Dual Color Dual Fusion Probe
goldFISH DF088 EGR1/TERT Dual Color Probe
goldFISH DF016 BCL6 Dual Color Break Apart Probe
goldFISH DF129 EWSR1/FLI1 Dual Color Dual Fusion Probe
goldFISH DF100 PAX3 Dual Color Break Apart Probe
goldFISH DF094 FGFR2 Dual Color Break Apart Probe
goldFISH DF282 MYB/CSP6 Dual Color Probe
goldFISH DF043 EWSR1 Dual Color Break Apart Probe
goldFISH DF458 TP73/ABL2 Dual Color Probe
goldFISH DF103 EGFR/CSP7 Dual Color Probe
goldFISH DF035 CCND1/IGH Dual Color Dual Fusion Probe
goldFISH DF081 COL1A1/PDGFB Dual Color Dual Fusion Probe
goldFISH DF068 MDM2/CSP12 Dual Color Probe
goldFISH DF207 MAFB/IGH Dual Color Dual Fusion Probe
goldFISH DF044 MYCN/CSP2 Dual Color Probe
goldFISH DF069 p53/CSP17 Dual Color Probe
goldFISH DF208 FGFR3/IGH Dual Color Dual Fusion Probe
goldFISH DF045 AML1/ETO Dual Color Dual Fusion Probe
goldFISH DF209 MYEOV/IGH Dual Color Dual Fusion Probe
goldFISH DF046 BCR/ABL Dual Color Dual Fusion Probe
goldFISH DF101 ROS1 Dual Color Break Apart Probe
goldFISH DF037 IGH Dual Color Break Apart Probe
goldFISH DF091 SS18 Dual Color Break Apart Probe
goldFISH DF480 D20S108/20q13 Dual Color Probe
goldFISH DF027 IRF4 Dual Color Break Apart Probe
goldFISH DF073 MYB Dual Color Break Apart Probe
goldFISH DF059 D7S486/CSP7 Dual Color Probe
goldFISH DF204 ATM/CSP11 Dual Color Probe
goldFISH DF047 PML/RARA Dual Color Dual Fusion Probe
goldFISH DF040 PPARG/CSP3 Dual Color Probe
goldFISH DF015 BCL2 Dual Color Break Apart Probe
goldFISH DF006 MET/CSP7 Dual Color Probe
goldFISH DF001 HER2/CSP17 Dual Color Probe
goldFISH DF514 CDKN2C/CKS1B Dual Color Probe
goldFISH DF005 ALK Dual Color Break Apart Probe
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device