FDA UDI In Commercial Distribution 🇺🇸 United States

INSTANT-VIEW FSH Midstream Cassette Test, 2t

DI: 10796918002003 · Model: 02-2560-2 · ALFA SCIENTIFIC DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2

Basic Information

Brand Name
INSTANT-VIEW FSH Midstream Cassette Test, 2t
Primary DI
10796918002003
Version / Model
02-2560-2
Company Name
ALFA SCIENTIFIC DESIGNS, INC.
Labeler DUNS
176391167
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2018-10-29
Public Version
2
Public Version Date
2019-05-02
Public Version Status
Update
Public Device Record Key
a1a09bd5-06dd-41e6-b3f9-6738d6a201ad

Device Description

INSTANT-VIEW FSH Midstream Cassette Test, 2t

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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

Product Codes

Code Name
CGJ Radioimmunoassay, Follicle-Stimulating Hormone

GMDN Terms

Code Name
30512 Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Identifiers

Type ID
Primary 10796918002003
Unit of Use 00796918002006