FDA UDI In Commercial Distribution 🇺🇸 United States

Epredia

DI: 00673693248655 · Model: CytoRich Red Collection Fluid · RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Epredia
Primary DI
00673693248655
Version / Model
CytoRich Red Collection Fluid
Catalog Number
B9990802
Company Name
RICHARD-ALLAN SCIENTIFIC COMPANY
Labeler DUNS
929504710
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-07-21
Public Version
1
Public Version Date
2024-07-29
Public Version Status
New
Public Device Record Key
7102af1f-e41d-48d9-8508-ae8c6fcbbce3

Device Description

Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.

Device Characteristics

Single Use
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LEA Preservative, Cytological

GMDN Terms

Code Name
57752 Saccamanno solution IVD

Identifiers

Type ID
Primary 00673693248655