Clearblue N/A

GUDID 10633472602242

CB Menopause Stage Indicator 5ct US

SPD SWISS PRECISION DIAGNOSTICS GMBH

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Primary Device ID10633472602242
NIH Device Record Key94eb3d1a-994d-4827-8da3-624dbeb70b43
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearblue
Version Model NumberMenopause Stage Indicator
Catalog NumberN/A
Company DUNS483609579
Company NameSPD SWISS PRECISION DIAGNOSTICS GMBH
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx
Phone800-321-3279
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100633472000577 [Unit of Use]
GS100633472602245 [Primary]
GS110633472602242 [Package]
Contains: 00633472602245
Package: Shipping Case [6 Units]
In Commercial Distribution

FDA Product Code

NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-08
Device Publish Date2023-07-31

On-Brand Devices [Clearblue]

10633472601542A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearblue Rapid Detecti
10633472601344COTS Clearblue 25ct Ovulation + CB12 3ct Digital Pregnancy Bundle
00633472601323CB6 Visual Pregnancy 2ct US
10633472601207CBCOT Ovulation Advanced 25ct
10633472601153A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and 1 Cle
10633472601146CB12 Pregnancy Digital- 1CT
10633472601023A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid De
10633472601894CBCOT Ovulation Advanced 40ct
10633472601849CB11a Visual Pregnancy 1 Ct
10633472600767CBDOT Clearblue Ovulation Digital 10ct Dual
00633472600630CBHOT Visual Ovulation Stick 5 Ct
00633472600708ADOT Clearblue Advanced Ovulation 20ct March of Dimes Dual US
00633472600715ADOT Clearblue Advanced Ovulation 10ct March of Dimes Dual US
10633472600224Clearblue Fertility Monitor with touch screen 1ct US
00633472022258Clearblue Fertility Monitor with touch screen fertility test sticks 30 ct
10633472601719CB11a Visual Pregnancy 2 Ct
10633472276894Clearblue Digital Ovulation Test 20ct dual
10633472602051A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid
10633472602099Clearblue Advanced Period Tracker 18ct
10633472602198A convenience kit consisting of 25 Clearblue Digital Ovulation Tests and 2 Clearblue Rapid Dete
10633472602181A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests and 2 Clearblue Ra
10633472602259Clearblue Preg Dig CB15 3ct US
10633472602235CB Triple Conf Preg Test 3ct US
10633472602297CB Preg Vis CB16 ED 5ct US
10633472602280CB Preg Vis CB16 ED 3ct US
10633472602273CB Preg Vis CB16 ED 2ct US
10633472602266Clearblue Preg Dig CB15 2ct - US
10633472602242CB Menopause Stage Indicator 5ct US
10633472602365CB Preg Vis CB16 ED 1ct US
10633472602341A convenience kit consisting of 1 Digital pregnancy test + 1 visual pregnancy test
10633472602334A convenience kit consisting of 2 Digital pregnancy tests + 2 visual pregnancy tests
10633472602327A convenience kit consisting of 2 Digital Pregnancy Tests + 8 Visual Pregnancy Tests
10633472602310Clearblue Preg Dig CB15 5ct - US
10633472602303Clearblue Preg Dig CB15 1ct - US

Trademark Results [Clearblue]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARBLUE
CLEARBLUE
85941962 not registered Dead/Abandoned
BBVA Compass Bancshares, Inc.
2013-05-24
CLEARBLUE
CLEARBLUE
78699151 3326587 Dead/Cancelled
DAFCA, Inc.
2005-08-24
CLEARBLUE
CLEARBLUE
78231358 2924246 Live/Registered
SPD SWISS PRECISION DIAGNOSTICS GMBH
2003-03-28
CLEARBLUE
CLEARBLUE
78231341 2958057 Live/Registered
SPD Swiss Precision Diagnostics GmbH
2003-03-28
CLEARBLUE
CLEARBLUE
76262360 2715082 Dead/Cancelled
AES Power Direct, L.L.D.
2001-05-24
CLEARBLUE
CLEARBLUE
76198958 not registered Dead/Abandoned
C-POOL USA, LLC
2001-01-24
CLEARBLUE
CLEARBLUE
76055271 2629967 Dead/Cancelled
CLEAR BLUE, INC.
2000-05-24
CLEARBLUE
CLEARBLUE
73633497 1492770 Live/Registered
UNIPATH LIMITED
1986-12-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.