FDA UDI In Commercial Distribution 🇺🇸 United States

IFOB CONTROLS

DI: 00695684742119 · Model: 74211 · GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2

Basic Information

Brand Name
IFOB CONTROLS
Primary DI
00695684742119
Version / Model
74211
Company Name
GERMAINE LABORATORIES, INC
Labeler DUNS
176458115
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2016-04-27
Public Version
3
Public Version Date
2020-04-06
Public Version Status
Update
Public Device Record Key
8125139a-261e-458a-8a83-209ced4c1927

Device Description

IFOB Controls

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
KHE Reagent, Occult Blood

GMDN Terms

Code Name
38218 Faecal occult blood IVD, control

Identifiers

Type ID
Primary 00695684742119
Unit of Use 00695684742112