FDA UDI In Commercial Distribution 🇺🇸 United States

Alinity

DI: 00380740117214 · Model: 06P0760 · Abbott GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Alinity
Primary DI
00380740117214
Version / Model
06P0760
Catalog Number
06P0760
Company Name
Abbott GmbH
Labeler DUNS
315786293
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-14
Public Version
15
Public Version Date
2023-12-21
Public Version Status
Update
Public Device Record Key
f8db65ef-a814-4164-83be-d82a1308164f

Device Description

Alinity s HTLV I/II Reagent 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
48524 Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Identifiers

Type ID
Primary 00380740117214

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius