FDA UDI In Commercial Distribution 🇺🇸 United States

Alinity

DI: 00380740203030 · Model: 06P0825 · ABBOTT LABORATORIES
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Alinity
Primary DI
00380740203030
Version / Model
06P0825
Catalog Number
06P0825
Company Name
ABBOTT LABORATORIES
Labeler DUNS
079226220
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-17
Public Version
1
Public Version Date
2025-09-25
Public Version Status
New
Public Device Record Key
31b2e641-a4f0-4b00-9143-8d8c092610b0

Device Description

Alinity s Chagas 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
52492 Trypanosoma cruzi total antibody IVD, control

Identifiers

Type ID
Primary 00380740203030

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius