FDA UDI In Commercial Distribution 🇺🇸 United States

Alinity

DI: 00380740177683 · Model: 04W5624 · Abbott GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Alinity
Primary DI
00380740177683
Version / Model
04W5624
Catalog Number
04W5624
Company Name
Abbott GmbH
Labeler DUNS
315786293
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-17
Public Version
1
Public Version Date
2024-01-25
Public Version Status
New
Public Device Record Key
508678b5-2015-42de-bbcf-382c7dfb21ec

Device Description

Alinity s Anti-HCV II Release Control Kit

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
41973 Hepatitis C virus total antibody IVD, control

Identifiers

Type ID
Primary 00380740177683

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius