FDA UDI Not in Commercial Distribution 🇺🇸 United States

Proteus OX19 Stained Suspension

DI: 05056080501635 · Model: R30953701 · REMEL EUROPE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Proteus OX19 Stained Suspension
Primary DI
05056080501635
Version / Model
R30953701
Company Name
REMEL EUROPE LIMITED
Labeler DUNS
232600853
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-21
Public Version
2
Public Version Date
2023-08-18
Public Version Status
Update
Public Device Record Key
24c500c4-36f1-473d-98fd-2d02a21d6668
Distribution End Date
2023-06-30

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
GSZ Antigens, Febrile (Weil-Felix), All Groups

GMDN Terms

Code Name
51301 Multiple Rickettsia species (spotted fever group) total antibody IVD, reagent

Identifiers

Type ID
Primary 05056080501635

Customer Contacts