FDA UDI In Commercial Distribution 🇺🇸 United States

VARIANT II TURBO

DI: 00847817015786 · Model: 270-2601 · BIO-RAD LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VARIANT II TURBO
Primary DI
00847817015786
Version / Model
270-2601
Catalog Number
2702601
Company Name
BIO-RAD LABORATORIES, INC.
Labeler DUNS
132528295
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-31
Public Version
1
Public Version Date
2023-02-08
Public Version Status
New
Public Device Record Key
8a5b6e1b-657f-47ed-bcea-bcbb2d059aa3

Device Description

VARIANT II TURBO Hemoglobin Testing System WITHOUT Computer

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
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
LDM INSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY

GMDN Terms

Code Name
35968 Glycated haemoglobin (HbA1C) analyser IVD

Identifiers

Type ID
Primary 00847817015786

Customer Contacts