FDA UDI Not in Commercial Distribution 🇺🇸 United States

e.p.t. Early Pregnancy Test

DI: 00045611953031 · Model: e.p.t. Analog · Nfi Consumer Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3

Basic Information

Brand Name
e.p.t. Early Pregnancy Test
Primary DI
00045611953031
Version / Model
e.p.t. Analog
Company Name
Nfi Consumer Products
Labeler DUNS
016785052
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
3
Record Status
Published
Publish Date
2017-11-28
Public Version
3
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
b7251cd4-9e4b-46cc-9f01-efb1f765427e
Distribution End Date
2018-02-01

Device Description

ept analog 3 Ct

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
54210 Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 00045611953031
Unit of Use 80045611953031

Customer Contacts

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Store at 2 – 30°C (36 – 86 °F)