Clearblue Pregnancy Test with Smart Countdown

GUDID 00633472002908

CB12 Pregnancy Digital 2 CT

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00633472002908
NIH Device Record Keyc07ab6fe-41f9-4ebf-8b35-c088568e6e91
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearblue Pregnancy Test with Smart Countdown
Version Model NumberCB12
Company DUNS483609579
Company NameSPD SWISS PRECISION DIAGNOSTICS GMBH
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
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

Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
Emailxx@xx.xx
Phone8003213279
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
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
GS100633472000072 [Unit of Use]
GS100633472002908 [Primary]
GS100633472032905 [Package]
Package: Shipping Case [24 Units]
In Commercial Distribution
GS100633472601378 [Package]
Package: Shipping Case [4 Units]
Discontinued: 2016-11-01
Not in Commercial Distribution
GS100633472601385 [Package]
Package: Shipping Case [12 Units]
Discontinued: 2017-04-26
Not in Commercial Distribution
GS100633472601644 [Package]
Package: Shipping Case [12 Units]
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 Date2019-12-02
Device Publish Date2016-06-30

On-Brand Devices [Clearblue Pregnancy Test with Smart Countdown]

00633472808760CB12 Digital Pregnancy 5 CT Dual
00633472002953CB12 Digital Pregnancy 3 CT Dual
00633472002908CB12 Pregnancy Digital 2 CT

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