FDA UDI In Commercial Distribution 🇺🇸 United States

PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN)

DI: 03573026227739 · Model: PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN) · BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48

Basic Information

Brand Name
PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN)
Primary DI
03573026227739
Version / Model
PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN)
Company Name
BIOMERIEUX SA
Labeler DUNS
276816717
Distribution Status
In Commercial Distribution
Device Count in Pkg
48
Record Status
Published
Publish Date
2020-08-14
Public Version
1
Public Version Date
2020-08-24
Public Version Status
New
Public Device Record Key
d5a703ed-2f61-4fe3-b962-e00961986c51

Device Description

The chamber features a sample loading system that places a spot on the microscope slide.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Expiration Date
Yes
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
Unit of Use 03573026615185
Primary 03573026227739