FDA UDI In Commercial Distribution 🇺🇸 United States

ARCHITECT

DI: 00380740156428 · Model: 06L3441 · ABBOTT LABORATORIES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ARCHITECT
Primary DI
00380740156428
Version / Model
06L3441
Catalog Number
06L3441
Company Name
ABBOTT LABORATORIES
Labeler DUNS
079226220
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-03
Public Version
2
Public Version Date
2023-08-25
Public Version Status
Update
Public Device Record Key
c42864a2-99b5-4e78-aef6-8896dd2470f0

Device Description

Quantia Alpha-1-Acid Glycoprotein

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
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

Product Codes

Code Name
LKL ALPHA-1-ACID-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

GMDN Terms

Code Name
53606 Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Identifiers

Type ID
Primary 00380740156428

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
High: 29 Degrees Celsius