FDA UDI In Commercial Distribution 🇺🇸 United States

AIMSTRIP URINE ANALYZER

DI: 00695684511203 · Model: 51120 · GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AIMSTRIP URINE ANALYZER
Primary DI
00695684511203
Version / Model
51120
Company Name
GERMAINE LABORATORIES, INC
Labeler DUNS
176458115
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-27
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
a93946c0-439b-4f09-ab2f-ad7fc9f8c6ff

Device Description

The AimStrip® Urine Analyzer / CT-120 Analyzer is intended for use in conjunction with the AimStrip® Urine Reagent Strips.

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
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

Product Codes

Code Name
KQO Automated Urinalysis System

GMDN Terms

Code Name
57861 Urine analyser IVD, point-of-care

Identifiers

Type ID
Primary 00695684511203