First Signal

GUDID 10751774013730

First Signal 5D Pregnancy Cassette

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10751774013730
NIH Device Record Keycf822540-b5b3-4dc0-b9e9-9416ef7c8366
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Signal
Version Model NumberOne Step Pregnancy Test
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

Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
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
GS100751774013733 [Primary]
GS110751774013730 [Package]
Contains: 00751774013733
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-06
Device Publish Date2023-03-29

On-Brand Devices [First Signal]

10751774356127PLPL First Signal DPS Early Result
00751774356113PLPL First Signal SPS Early Result
10751774013730First Signal 5D Pregnancy Cassette

Trademark Results [First Signal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIRST SIGNAL
FIRST SIGNAL
90367462 not registered Live/Pending
Abbott Rapid Diagnostics International Unlimited Company
2020-12-08

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