FDA UDI In Commercial Distribution 🇺🇸 United States

Instant-View HCG Midstream Cassette

DI: 00796918000019 · Model: 02-2480 · ALFA SCIENTIFIC DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Instant-View HCG Midstream Cassette
Primary DI
00796918000019
Version / Model
02-2480
Company Name
ALFA SCIENTIFIC DESIGNS, INC.
Labeler DUNS
176391167
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
4
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
ba3fec94-565f-4258-8892-79f6ce1e16b5

Device Description

HCG Midstream Cassette

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
LCX Kit, Test, Pregnancy, Hcg, Over The Counter

GMDN Terms

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

Identifiers

Type ID
Primary 00796918000019