FDA UDI In Commercial Distribution 🇺🇸 United States

Quantum S2

DI: G225QSSX370 · Model: QSS-X37 · Pathcom Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Quantum S2
Primary DI
G225QSSX370
Version / Model
QSS-X37
Company Name
Pathcom Systems Corporation
Labeler DUNS
845346506
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-05-01
Public Version
1
Public Version Date
2022-05-09
Public Version Status
New
Public Device Record Key
9d8000db-e3c3-46d2-8e65-c6b1960dcc52

Device Description

The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.

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
Yes
Has Lot/Batch Number
No
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 G225QSSX370