FDA UDI In Commercial Distribution 🇺🇸 United States

SUNRISE-RC/TW EVOLYZER

DI: 09120052071207 · Model: 30087505 02 · Tecan Austria GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SUNRISE-RC/TW EVOLYZER
Primary DI
09120052071207
Version / Model
30087505 02
Catalog Number
30087505
Company Name
Tecan Austria GmbH
Labeler DUNS
301237509
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-06
Public Version
1
Public Version Date
2023-07-14
Public Version Status
New
Public Device Record Key
70eb8291-fbb2-4eb4-b9e8-bf2d57c19810

Device Description

microplate reader - intended to be integrated in robotic solutions

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
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

GMDN Terms

Code Name
57862 Microplate reader IVD, automated/semi-automated

Identifiers

Type ID
Primary 09120052071207

Customer Contacts

Phone
+18003525128