Automatic High-throughput Exosome Extractor · ZRM-C-AH-A
Zhaorui Medical (Shenzhen) Co., LTD
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- false
- Commercial distribution status
- In Commercial Distribution
- Public device record key
- 37711114-1028-4604-9ef0-7e9e61b01f62
- Has serial number
- true
- Public version date
- 2022-09-09
- Is direct marking exempt
- false
- Public version number
- 1
- Labeler duns number
- 601717757
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- ZRM-C-AH-A
- Has manufacturing date
- true
- Brand name
- Automatic High-throughput Exosome Extractor
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- true
- Has lot or batch number
- true
- Company name
- Zhaorui Medical (Shenzhen) Co., LTD
- Public version status
- New
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2022-09-01
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- false
- Identifiers
- ID
- 06975064320002
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- JJH
- Name
- Clinical Sample Concentrator
- Harmonized identifiers (openFDA)
- Device name
- Clinical Sample Concentrator
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.2310
- Device class
- 1
- Gmdn terms
- Code
- 58386
- Name
- Centrifugal sample concentrator
- Implantable
- false
- Code status
- Active
- Definition
A mains electricity (AC-powered) laboratory device designed to condense fluid clinical specimens (e.g., serum, urine, cerebrospinal fluid, ascites) using centrifugal rotation in order to harvest and preserve the particulate matter. Commonly known as a cyto-spin, it separates fluid from the solid particles, or cellular elements, of a specimen so they are more concentrated. It typically consists of a centrifuge with various rotor heads, microtitre plates, tubes, microscope slides, funnels and/or cups to which the sample is added, and absorptive material, filters, fluid collecting traps or a vacuum source utilized to separate and remove the liquid component.