FDA UDI In Commercial Distribution 🇺🇸 United States

Anti-H (Ulex europaeus)

DI: 10888234000723 · Model: 0007151 · IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Anti-H (Ulex europaeus)
Primary DI
10888234000723
Version / Model
0007151
Catalog Number
0007151
Company Name
IMMUCOR, INC.
Labeler DUNS
061446282
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-15
Public Version
3
Public Version Date
2021-06-08
Public Version Status
Update
Public Device Record Key
58c1b6dd-a003-4496-9560-981ae43adaa2

Device Description

Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.

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

Product Codes

Code Name
KSI Lectins And Protectins

GMDN Terms

Code Name
52577 Anti-H red blood cell grouping IVD, lectin

Identifiers

Type ID
Primary 10888234000723

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
1 – 10 Degrees Celsius