FDA UDI Not in Commercial Distribution 🇺🇸 United States

ABBOTT PRISM

DI: 00380740030445 · Model: 1A75-02 · ABBOTT LABORATORIES
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ABBOTT PRISM
Primary DI
00380740030445
Version / Model
1A75-02
Catalog Number
01A7502
Company Name
ABBOTT LABORATORIES
Labeler DUNS
079226220
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-01-31
Public Version
5
Public Version Date
2023-07-10
Public Version Status
Update
Public Device Record Key
17cf856d-37fe-406e-bfed-306f0957d97f
Distribution End Date
2023-03-21

Device Description

ABBOTT PRISM Activator Concentrate

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
61163 Chemiluminescent immunoassay oxidizing reagent IVD

Identifiers

Type ID
Primary 00380740030445

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius