FDA Registration
Active
🇩🇪 Germany
INSM1 (SP493) Rabbit Monoclonal Primary Antibody
Reg #: 9610529
·
FEI: 3002806560
·
Expires 2025
Products
1
Proprietary Names
140
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROCHE DIAGNOSTICS GMBH
- Registration Number
- 9610529
- FEI Number
- 3002806560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NONNENWALD 2
- City
- PENZBERG Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
US Agent
- Business Name
- Roche Diagnostics Operations Inc
- Contact Name
- Brian Frazier
- Address
- 9115 Hague Rd
- City
- Indianapolis
- State
- IN
- ZIP
- 46256
- Country
- US
- [email protected]
- Phone
- 317 5214603
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2012-01-17 |
Proprietary Names
INSM1 (SP493) Rabbit Monoclonal Primary Antibody
CONFIRM anti-Ki-67 (30-9)
anti-ERG (EPR3864) Rabbit Monoclonal Primary Antibody
CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody
CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody
anti-Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody
anti-p504s (SP116)
CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody
CONFIRM anti-Desmin (DE-R-11) Primary Antibody
CONFIRM anti-LMO2 (1A9-1) Mouse Monoclonal Primary Antibody
CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody
anti-CD30 (Ber-H2) Mouse Monoclonal Primary Antibody
CONFIRM anti-S100 (4C4.9) Primary Antibody
VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody
Amplification Kit
iVIEW DAB Detection Kit
anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody
VENTANA anti-Cyclin D1 (SP4-R) Rabbit Monoclonal Primary Antibody
CONFIRM anti-Vimentin (V9) Primary Antibody
FITC Anti-Fibrinogen Primary Antibody
CONFIRM anti-Synaptophysin (SP11) Rabbit Monoclonal Primary Antibody
Anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody
CONFIRM anti-CD23 (SP23) Rabbit Monoclonal Primary Antibody
FITC Anti-IgM Primary Antibody
anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody
VENTANA TFF3 (7F1.21) Mouse Monoclonal Primary Antibody
VENTANA iView DAB Universal Kit (export)
CONFIRM anti-CD20 (L26) Primary Antibody
VENTANA PTEN (SP218) Rabbit Monoclonal Primary Antibody
anti-EGFR E746-A750 del (SP111) Rabbit Monoclonal Primary Antibody
anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody
CONFIRM anti-MITF (C5/D5) Mouse Monoclonal Primary Antibody
CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody
ultraView Universal DAB Detection Kit
FITC Anti-Albumin Primary Antibody
anti-Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody
CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody
anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody
CONFIRM anti-CD30 (Ber-H2) Primary Antibody
FITC Anti-Kappa Primary Antibody
Negative Control (Monoclonal)
CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody
Melanoma Triple Cocktail (HMB45+A103+T311) Primary Antibody
CONFIRM anti-ALK1 (ALK01) Primary Antibody
Anti-CD43 (L60) Mouse Monoclonal Primary Antibody
anti-CD44 (SP37) Rabbit Monoclonal Primary Antibody
CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody
CONFIRM anti-Thyroid Transcription Factor-1 (8G7G3/1) Mouse Monoclonal Primary Antibody
VENTANA PD-L1 (SP142) IHC Assay (export)
CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody
CONFIRM anti-p53 (DO7) Primary Antibody
CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody
CONFIRM anti-p53 (DO-7) Primary Antibody
FITC Anti-IgA Primary Antibody
CONFIRM anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody
VENTANA Basal Cell Cocktail (34bE12+p63)
anti-MUC1 (H23) Mouse Monoclonal Primary Antibody
CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody
CONFIRM Negative Control Rabbit Ig
CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody
FITC anti-Lambda Primary Antibody
CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody
Anti-Cytokeratin (CAM 5.2) Mouse Monoclonal Primary Antibody
Rabbit Monoclonal Negative Control Ig
CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody
OptiView Amplification Kit
anti-Cytokeratin 10 (SP99) Rabbit Monoclonal Primary Antibody
CONFIRM Anti-CD34 (QBEnd/10) Mouse Monoclonal Primary Antibody
CONFIRM anti-Tyrosinase (T311) Mouse Monoclonal Primary Antibody
CONFIRM anti-CD79a (SP18) Rabbit Monoclonal Primary Antibody
Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody
VENTANA anti-E-Cadherin (36) Mouse Monoclonal Primary Antibo
anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody
VENTANA PD-L1 (SP263) Assay (export)
Bluing Reagent
VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody
CONFIRM anti-Lambda Rabbit Polyclonal Primary Antibody
FITC Anti-C3 Primary Antibody
CONFIRM anti-Epidermal Growth Factor Receptor (3C6) Primary Antibody
anti-CEA (TF 3H8-1) Primary Antibody
Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody
Endogenous Biotin Blocking Kit
CONFIRM anti-CD68 (KP-1) Primary Antibody
CONFIRM anti-Topoisomerase IIa (JS5B4) Rabbit Monoclonal Primary Antibody
anti-bcl-2 (SP66) Rabbit Monoclonal Primary Antibody
VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal (export)
Anti-Chromogranin A (LK2H10) Primary Antibody
CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody
ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (export)
CONFIRM anti-Vimentin (Vim 3B4) Primary Antibody
OptiView DAB IHC Detection Kit
CONFIRM anti-Keratin (34?E12) Mouse Monoclonal Primary Antibody
Anti-p53 (Bp53-11) Primary Antibody
FITC anti-C1q Primary Antibody
anti-Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody
CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody
CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody
FITC Anti-IgG Primary Antibody
VENTANA anti-p120 catenin (98) Mouse Monoclonal Primary Antibody
CONFIRM anti-HER-2/neu (4B5) Primary Antibody
CONFIRM anti-S100 (Polyclonal) Primary Antibody
CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Antibody
CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody
VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody
anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
anti-p40 (BC28) Mouse Monoclonal Primary Antibody
CONFIRM anti-Cytokeratin (AE1) Primary Antibody
VENTANA PD-L1 SP263
NeuVision Blocking Reagent
CONFIRM anti-Melanosome (HMB45) Mouse Monoclonal Primary Antibody
VENTANA MSLN (SP74) ASSAY
VENTANA Protease Neg Reagent Control-IVD
VENTANA CLDN18 [43-14A] Assay
VENTANA pan-TRK (EPR17341) Assay
Ventana ROS1 (SP384) Rb Mono Primary Ab
CD117(EP10) Rabbit Monoclonal PAB
anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody
VENTANA Silver ISH DNP Detection Kit
VENTANA Red ISH DIG Detection Kit
ECL-LC
PRAME (EPR20330) Rbt Mono PAB 50
VENTANA HA Assay
ATRX CM Rabbit Polyclonal Antibody
RABBIT ANTI-DNP ANTIBODY
CONFIRM anti-MSH6 (44) Mouse Monoclonal
IDH1 R132H (MRQ-67) CM Rabbit Monoclonal
PRAME (EPR20330) Rbt Mono PAB 250
VENTANA DLL3 (SP347) Assay
p40 (SP225) Rabbit Monoclonal PAB
VENTANA FGFR2b (FPR2-D) Assay 1
VENTANA anti-EREG (SP326) Rabbit Monoclonal Primary Antibody
VENTANA anti-AREG (SP272) Rabbit Monoclonal Primary Antibody
CD68 (SP251v18) Rabbit Monoclonal Antibody
VENTANA U6 DIG Probe
VENTANA Magenta ISH DIG Detection Kit
CD8 (SP239) Rabbit Monoclonal PAB
VENTANA Silver ISH BF Detection Kit
VENTANA U6 BF Probe
ISH TSA Ancillary Kit
Establishment Types
Manufacture Medical Device