FDA UDI In Commercial Distribution 🇺🇸 United States

INSTANT-VIEW Pregnancy Combo Dip-Strip Test

DI: 10796918000085 · Model: 02-2488 · ALFA SCIENTIFIC DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50

Basic Information

Brand Name
INSTANT-VIEW Pregnancy Combo Dip-Strip Test
Primary DI
10796918000085
Version / Model
02-2488
Company Name
ALFA SCIENTIFIC DESIGNS, INC.
Labeler DUNS
176391167
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2016-09-21
Public Version
4
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
c62a0712-8847-4b9a-bb50-1d69d84c4f4b

Device Description

INSTANT-VIEW HCG Combo Dip-Strip Test

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
JHI Visual, Pregnancy Hcg, Prescription Use

GMDN Terms

Code Name
33819 Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Identifiers

Type ID
Primary 10796918000085
Unit of Use 00796918000088