FDA UDI In Commercial Distribution 🇺🇸 United States

Solidscreen II Anti-D (RH1) Blend

DI: 07611969951512 · Model: 806530100 · Bio-Rad Medical Diagnostics GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Solidscreen II Anti-D (RH1) Blend
Primary DI
07611969951512
Version / Model
806530100
Catalog Number
806530100
Company Name
Bio-Rad Medical Diagnostics GmbH
Labeler DUNS
312576506
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-17
Public Version
3
Public Version Date
2021-05-24
Public Version Status
Update
Public Device Record Key
19854336-11ce-4051-9f8c-b52f05ed7efd

Device Description

Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with TANGO instruments; 5ml

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
58904 Partial (variant) Rh(D) category VI/weak Rh(D) red cell grouping IVD, antibody

Identifiers

Type ID
Primary 07611969951512

Customer Contacts

Phone
800-224-6723

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius