FDA UDI Not in Commercial Distribution 🇺🇸 United States

RAMP® Flu A + B TEST KIT; 25 TESTS

DI: 10627966005176 · Model: C1107 · Response Biomedical Corp
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RAMP® Flu A + B TEST KIT; 25 TESTS
Primary DI
10627966005176
Version / Model
C1107
Company Name
Response Biomedical Corp
Labeler DUNS
248609018
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-31
Public Version
3
Public Version Date
2018-04-13
Public Version Status
Update
Public Device Record Key
98c85364-2db3-4783-905d-a518c82bbf32
Distribution End Date
2018-01-11

Device Characteristics

Single Use
Yes
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
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
49117 Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

Identifiers

Type ID
Primary 10627966005176