FDA UDI In Commercial Distribution 🇺🇸 United States

Tina-quant Alpha 1-Acid Glycoprotein Gen.2

DI: 04015630919529 · Model: 03333795190 · Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Tina-quant Alpha 1-Acid Glycoprotein Gen.2
Primary DI
04015630919529
Version / Model
03333795190
Catalog Number
03333795190
Company Name
Roche Diagnostics GmbH
Labeler DUNS
315028860
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-02-08
Public Version
3
Public Version Date
2021-08-13
Public Version Status
Update
Public Device Record Key
ed129003-196e-428f-bd30-d83379bfa274

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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 04015630919529