FDA UDI In Commercial Distribution 🇺🇸 United States

Epredia

DI: 05051663518109 · Model: LV 720 Reagent Tray Kit · SHANDON DIAGNOSTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Epredia
Primary DI
05051663518109
Version / Model
LV 720 Reagent Tray Kit
Catalog Number
A80510137
Company Name
SHANDON DIAGNOSTICS LIMITED
Labeler DUNS
219103512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-16
Public Version
1
Public Version Date
2024-02-26
Public Version Status
New
Public Device Record Key
9eacac8b-b90a-43a7-b8d0-2105bc941f1e

Device Description

Autostainer Automated Slide Stainer - Accessory

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KPA Slide Stainer, Automated

GMDN Terms

Code Name
15599 Microscope slide stainer IVD

Identifiers

Type ID
Primary 05051663518109