Epredia

Autostainer Automated Slide Stainer - Accessory

Registry build 21.09.26
14manufacturers in China registered for this device type
54catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Shandong (2).

Chinese manufacturers registered for FDA product code KPA
Manufacturer City Province Registered as Device types
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Diatrust Medical Co., Ltd. Nanjing Jiangsu Manufacturer 48
Labpeak Co., Ltd. Jinan Shandong Manufacturer 43
Scitek Global Co., Ltd. Jinan Shandong Manufacturer 43
Zhejiang Gene Science Co., Ltd. Shaoxing Zhejiang Manufacturer 31
AVE Science & Technology Co., Ltd. Changsha Hunan Manufacturer 22
Wuhan Landing Intelligence Medical Co., Ltd. Wuhan Hubei Manufacturer 17
Leica Instruments (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 11
Dakewe(Shenzhen) Medical Equipment Co., Ltd. Shenzhen Guangdong Repacker / relabeller 9
Henan Celnovte Biotechnology Co., Ltd. Zhengzhou Henan Manufacturer 8
Hangzhou Healthsky Biotechnology Co., Ltd. Hangzhou Zhejiang Manufacturer 6
Jiangsu Medomics Medical Technology Co., Ltd. Nanjing Jiangsu Contract manufacturer 5

Showing 12 of 14. All 14 manufacturers in China registered for Slide Stainer, Automated

Record

Regulatory record for Epredia
Listed by Shandon Diagnostics Limited, United Kingdom
FDA product code KPA
Device type Slide Stainer, Automated
Device class Class 1
Regulation 21 CFR 864.3800
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-02-15
Record revised 2023-07-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
Reagent Pot (Pk of 3) In distribution
Reagent Rack In distribution
Reagent Bottle Rack In distribution
AUTOSTAINER 480S PT 220V In distribution
Gemini Baskets (5) In distribution
12ml Vial with Cap Kit In distribution
Basket and Carrier In distribution
Evaporation Cover In distribution
AUTOSTAINER 360 & PT 110V In distribution
PC for 360 Instrument In distribution
AUTOSTAINER 260 In distribution
AUTOSTAINER 480S In distribution
AUTOSTAINER 360 & PT 220V In distribution
AUTOSTAINER 720 In distribution
AUTOSTAINER 720 & PT 110V In distribution
Slide Clip White (Pk of 25) In distribution
GEMINI AS In distribution
Slide Barcode Label Kit In distribution
Reagent Pot Insert In distribution
GEMINI AS In distribution
PC for 720 Instrument In distribution
Flap Label Kit In distribution
PC Connector Bracket Kit In distribution
Tubing Assy Non Haz Waste In distribution
AUTOSTAINER 720 In distribution
AUTOSTAINER 480S PT 110V In distribution
AUTOSTAINER 720 & PT 220V In distribution
GEMINI AS In distribution
Reagent Barcode Label Kit In distribution
Tray for 40 Autostainer In distribution
Sakura Carrier (PK of 5) In distribution
Slide Rack Carrier In distribution
Slide Rack Adaptor In distribution
Slide Rack Kit In distribution
AUTOSTAINER 720 & PT 110V In distribution
PT Tank Lid Pins and Lid In distribution
AUTOSTAINER 360 In distribution
PC for 480S Instrument In distribution
Gemini Baskets (5) In distribution
Vent Adaptor Kit In distribution
Tubing Assy Haz Waste In distribution
Bottle Kit inc Buffer In distribution
LINISTAT In distribution
LV 720 Reagent Tray Kit In distribution
GEMINI AS In distribution
Single Station Staining Dishes (Pk of 10) In distribution
Inlet Hose 2.5M Long In distribution
Multireagent Pot Cover In distribution
PT MODULE TS 220-240V In distribution
AUTOSTAINER 480S In distribution
LINISTAT In distribution
Single Reagent Pot Cover In distribution
480S Reagent Rack Kit In distribution
PT MODULE TS 100-120V In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Thermo Fisher Shandon Diagnostics Limited 27
Bond Leica Biosystems Melbourne PTY Ltd 21
HistoPro® Rushabh Instruments, LLC 5
intelliPATH Plus Biocare Medical, LLC 4
Alinity Abbott Laboratories 4
intelliPATH MAX Biocare Medical, LLC 4
Bond Leica Biosystems Newcastle Ltd 4
Dako Agilent Technologies, Inc 3
Advia Autoslide® Slide Maker Stainer Siemens Healthcare Diagnostics Inc 3
Bond-Prime automated stainer Leica Biosystems Melbourne PTY Ltd 2
Decloaking Chamber™ NxGen Reconditioned Biocare Medical, LLC 2
QuickSlide™ Hardy Diagnostics 2

Showing 12 of 153. All products under Slide Stainer, Automated

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer