FDA UDI In Commercial Distribution 🇺🇸 United States

BOND

DI: 09349458001261 · Model: BOND Mixing Stations (5 pack) · LEICA BIOSYSTEMS MELBOURNE PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BOND
Primary DI
09349458001261
Version / Model
BOND Mixing Stations (5 pack)
Catalog Number
S21.1971
Company Name
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Labeler DUNS
753184944
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-07-18
Public Version
1
Public Version Date
2022-07-26
Public Version Status
New
Public Device Record Key
145f196c-b2b7-40ab-81bb-4c194b3037b4

Device Description

BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be mixed just before use. The mixing of the reagents is determined by the software, depending on reagent type.

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 09349458001261