Accu-Clear Pregnancy Test

GUDID 00751774975901

FPPL Accuclear Visual Pregnancy Stick 2 CT Combo Tag

SPD SWISS PRECISION DIAGNOSTICS GMBH

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Primary Device ID00751774975901
NIH Device Record Key35753374-c8d3-4dcc-ac24-caf609ffcff5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Clear Pregnancy Test
Version Model NumberFPPL
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

Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
Emailxx@xx.xx
Phone888-698-5031
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
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
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
GS100633472000133 [Unit of Use]
GS100751774975901 [Primary]
GS110751774975908 [Package]
Package: Shipping Case [24 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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

On-Brand Devices [Accu-Clear Pregnancy Test]

00751774975932FPPL Accuclear Visual Pregnancy Stick 3 CT CKPT
00751774975901FPPL Accuclear Visual Pregnancy Stick 2 CT Combo Tag

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