Clearblue Easy Ovulation Kit N/A

GUDID 00633472155642

A convenience kit consisting of 7 Clearblue Easy Ovulation Test device and 1 Clearblue Pregnancy Test with Smart Countdown device

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00633472155642
NIH Device Record Key59a6d66c-3c89-4e3a-8806-c739e9809e87
Commercial Distribution Discontinuation2016-10-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameClearblue Easy Ovulation Kit
Version Model NumberHOT / CB12
Catalog NumberN/A
Company DUNS483609579
Company NameSPD SWISS PRECISION DIAGNOSTICS GMBH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100633472155642 [Primary]
GS100633472600548 [Package]
Package: Shipping case [6 Units]
Discontinued: 2016-10-31
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2016-06-30

Devices Manufactured by SPD SWISS PRECISION DIAGNOSTICS GMBH

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00633472602399 - Clearblue2024-08-12 Clearblue Ovul Dig 30ct. US
00633472602405 - Clearblue2024-08-12 A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnancy tests
00633472602412 - Clearblue2024-08-12 A convenience kit consisting of 15 Advanced Digital Ovulation tests + 1 Rapid Detection pregnancy tests
10761706168537 - CVP Health2024-04-12 McLane (CVP Health) DPS +/-
10633472602303 - Clearblue2024-02-14 Clearblue Preg Dig CB15 1ct - US
10633472602310 - Clearblue2024-02-14 Clearblue Preg Dig CB15 5ct - US
10633472602327 - Clearblue2024-02-14 A convenience kit consisting of 2 Digital Pregnancy Tests + 8 Visual Pregnancy Tests

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