First Signal One Step Pregnancy Test

GUDID 00751774975949

First Signal Pregnancy Cassette

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00751774975949
NIH Device Record Key986ca277-5931-4d59-8050-ba2afbe0d391
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Signal One Step Pregnancy Test
Version Model NumberFHC - 102H
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 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

Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
Emailxx@xx.xx
Phone800-899-7353
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
GS100751774975949 [Primary]
GS110751774975946 [Package]
Package: Shipping Case [48 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 Date2016-07-30

Devices Manufactured by SPD SWISS PRECISION DIAGNOSTICS GMBH

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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
10633472602334 - Clearblue2024-02-14 A convenience kit consisting of 2 Digital pregnancy tests + 2 visual pregnancy tests
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