FDA UDI In Commercial Distribution 🇺🇸 United States

Anti-A (Murine Monoclonal) Series 1

DI: 10888234000525 · Model: 0006400 · IMMUCOR, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Anti-A (Murine Monoclonal) Series 1
Primary DI
10888234000525
Version / Model
0006400
Catalog Number
0006400
Company Name
IMMUCOR, INC.
Labeler DUNS
061446282
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-14
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
2f6ac484-3924-4f3c-91f5-a8c4fa0abf25

Device Description

Anti-A (Murine Monoclonal) Series 1 is intended for use in slide, tube, microplate and automated tests, for the detection of the A antigen.

Device Characteristics

Single Use
No
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
52532 Anti-A red blood cell grouping IVD, antibody

Identifiers

Type ID
Primary 10888234000525

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
1 – 10 Degrees Celsius