DEVICE: BABYLife (00816862024418)
Device Identifier (DI) Information
BABYLife
W52-S-SQ-25BX
In Commercial Distribution
WONDFO USA CO., LTD.
W52-S-SQ-25BX
In Commercial Distribution
WONDFO USA CO., LTD.
25 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
65841 | Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 4 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6c9ae674-475f-4dca-8ea5-01f04ec788a1
May 30, 2024
1
May 22, 2024
May 30, 2024
1
May 22, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10816862024415 | 20 | 00816862024418 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00816862024425
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
630-468-2199
wondfo@wondfousa.com
wondfo@wondfousa.com