DEVICE: Clearblue (00633472602245)
Device Identifier (DI) Information
Clearblue
Menopause Stage Indicator
In Commercial Distribution
N/A
SPD SWISS PRECISION DIAGNOSTICS GMBH
Menopause Stage Indicator
In Commercial Distribution
N/A
SPD SWISS PRECISION DIAGNOSTICS GMBH
CB Menopause Stage Indicator 5ct US
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
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 |
---|
Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
94eb3d1a-994d-4827-8da3-624dbeb70b43
August 08, 2023
1
July 31, 2023
August 08, 2023
1
July 31, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10633472602242 | 6 | 00633472602245 | In Commercial Distribution | Shipping Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00633472000577
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-321-3279
xx@xx.xx
xx@xx.xx