FDA UDI In Commercial Distribution 🇺🇸 United States

UA DIPTUBE CONTROLS 4X12ML

DI: 00695684511425 · Model: 51142 · GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4

Basic Information

Brand Name
UA DIPTUBE CONTROLS 4X12ML
Primary DI
00695684511425
Version / Model
51142
Company Name
GERMAINE LABORATORIES, INC
Labeler DUNS
176458115
Distribution Status
In Commercial Distribution
Device Count in Pkg
4
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
59c5b4eb-dde2-4b67-8262-e70455f5a0c8

Device Description

Controls used with 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
JJW Urinalysis Controls (Assayed And Unassayed)

GMDN Terms

Code Name
30219 Multiple urine analyte IVD, control

Identifiers

Type ID
Primary 00695684511425
Unit of Use 00695684511421