FDA UDI In Commercial Distribution 🇺🇸 United States

AIM RF TEST

DI: 00695684351007 · Model: 35100 · GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

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Basic Information

Brand Name
AIM RF TEST
Primary DI
00695684351007
Version / Model
35100
Company Name
GERMAINE LABORATORIES, INC
Labeler DUNS
176458115
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
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
a93ec610-bfd5-4f56-a760-493a4b704f5a

Device Description

Latex test for Rheumatoid Factor

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
DHR System, Test, Rheumatoid Factor

GMDN Terms

Code Name
55112 Rheumatoid factor IVD, kit, agglutination

Identifiers

Type ID
Primary 00695684351007
Unit of Use 00695684351001