FDA UDI In Commercial Distribution 🇺🇸 United States

i6000™ Diagnostics

DI: 00810119676337 · Model: AS6030 · BIOGENEX LABORATORIES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
i6000™ Diagnostics
Primary DI
00810119676337
Version / Model
AS6030
Catalog Number
AS6030
Company Name
BIOGENEX LABORATORIES
Labeler DUNS
042697045
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-20
Public Version
1
Public Version Date
2023-04-28
Public Version Status
New
Public Device Record Key
2d2dc782-cf25-487e-8599-65af94d5cb67

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KEY Stainer, Tissue, Automated

GMDN Terms

Code Name
15599 Microscope slide stainer IVD

Identifiers

Type ID
Primary 00810119676337