FDA UDI In Commercial Distribution 🇺🇸 United States

Access Red Blood Cell Folate Lysing Agent

DI: 15099590201685 · Model: A14206 · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Access Red Blood Cell Folate Lysing Agent
Primary DI
15099590201685
Version / Model
A14206
Catalog Number
A14206
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
3
Public Version Date
2018-04-09
Public Version Status
Update
Public Device Record Key
45bb03e0-8e82-4745-9a79-a4a11f79de9b

Device Description

For the preparation of red blood cell hemolysates in the Access Folate Assay.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CGN Acid, Folic, Radioimmunoassay

GMDN Terms

Code Name
54455 Folate (vitamin B9) IVD, reagent

Identifiers

Type ID
Primary 15099590201685