FDA UDI In Commercial Distribution 🇺🇸 United States

Anti-Fya

DI: 00858400005077 · Model: 510215 · American National Red Cross
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Anti-Fya
Primary DI
00858400005077
Version / Model
510215
Company Name
American National Red Cross
Labeler DUNS
003255213
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-12
Public Version
3
Public Version Date
2026-03-13
Public Version Status
Update
Public Device Record Key
5650e245-e8fa-4689-9b48-77886f25bb0a

Device Description

Blood Grouping Reagent

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
52569 Anti-Fy^a red blood cell grouping IVD, antibody

Identifiers

Type ID
Primary 00858400005077

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
1 – 8 Degrees Celsius