Fully Automated IHC Stainer

GUDID 06971182571326

Dakewe (Shenzhen) Medical Equipment Co., Ltd.

Microscope slide stainer IVD
Primary Device ID06971182571326
NIH Device Record Key0f2092dd-e1d5-484d-852f-af698a126460
Commercial Distribution StatusIn Commercial Distribution
Brand NameFully Automated IHC Stainer
Version Model NumberNS40
Company DUNS554456618
Company NameDakewe (Shenzhen) Medical Equipment Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971182571326 [Primary]

FDA Product Code

KPASlide Stainer, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-06
Device Publish Date2024-12-27

Devices Manufactured by Dakewe (Shenzhen) Medical Equipment Co., Ltd.

06971182571005 - Adhesion Microscope Slides2025-01-06
06971182571159 - Microscope Slides2025-01-06
06971182571166 - Embedding Cassette2025-01-06
06971182571173 - Embedding Cassette2025-01-06
06971182571180 - Embedding Cassette2025-01-06
06971182571197 - Embedding Cassette2025-01-06
06971182571241 - Microscope Cover Glass2025-01-06
06971182571258 - CT520 Cryostat Microtome2025-01-06

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