First Signal

GUDID 00751774356113

PLPL First Signal SPS Early Result

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00751774356113
NIH Device Record Keyf16dcba8-5629-4f15-9139-d29707c7748b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Signal
Version Model NumberEarly Result 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

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
GS100751774356113 [Primary]
GS110751774356110 [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 Date2017-01-06

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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