FDA Registration
Active
🇺🇸 United States
10X Peroxidase Diluent II - K020
Reg #: 3007035884
·
FEI: 3007035884
·
Expires 2025
Products
1
Proprietary Names
39
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIAGNOSTIC BIOSYSTEMS
- Registration Number
- 3007035884
- FEI Number
- 3007035884
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6616 Owens Drive
- City
- Pleasanton
- State
- CA
- ZIP
- 94588
- Country
- US
Owner / Operator
- Firm Name
- Diagnostic BioSystems
- Operator Number
- 10024374
- Address
- 6616 Owens Drive
- City
- Pleasanton
- State
- CA
- Postal Code
- 94588
- Country
- US
- Correspondent
- Bipin C Gupta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2008-06-12 |
Proprietary Names
10X Peroxidase Diluent II - K020
Solution Pepsin - K009
Montage Tween 20 - K067-125AN
Background Blocker (1X) - K023, K023-HL
Primary Antibody Diluent - K004
DAPI - K108
Montage HistoZyme - K046-10 AN
DP3 for One-Step Deparaffinization - K082
CC/Mount - K002, K002-200
Montage EDTA Antigen Retrieval Solution - K038-500AN
Proteinase K - K030
Blue Hematoxylin - K097, K097-HL
Montage Opus Antigen Retrieval System - AR360
DBS Tube Bright Cleaning Kit - K094-100-HL, K094-HL
Broad Spectrum Negative Control - K053-06, K053-25, K053-100
DP2 (Dewax Solution 2) - K088-500-HL, K088-HL
Mouse & Rabbit Link - M006
Purple Hematoxylin - K095
Mini Elite PAP Pen - K042
DP1 (Dewax Solution 1) - K087-500-HL, K087-HL
Histo/Zyme - K046, K046-50
Montage Opus 365 - AR365
10X Secondary Antibody Diluent (With Background Reducing Component) - K022
Mouse on Mouse Blocking Reagent - K065
Blue Hematoxylin Kit - K100
Intensi/Fire - K045
Hematoxylin - K056-100AN
Peroxidase Block - K033
Alk. Phos. Enhancer - K011
FITC Diluent - FD001-100
ImmunoHisto-Sealer - K076, K076-200, K076-1000
12 mL Barcode Vials f 2-D Systems- K00029, K00029-5
Montage Citrate Antigen Retrieval Solution - K035-500AN
Rapid Histo-Sealer (10X) - K093
Elite PAP Pen - K039
Nuclear Fast Red - K098
Tissue Bond - K013, K013-200
Alkaline Phosphatase Diluent (With Background Reducing Component) - K028
Fluoromount - K024, K024-200
Establishment Types
Manufacture Medical Device