Equaline One Step Pregnancy Test

GUDID 00041163250949

FPPL Equaline DPS +/- (ER)

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00041163250949
NIH Device Record Key287ee115-615f-435b-85d3-db445b87b492
Commercial Distribution StatusIn Commercial Distribution
Brand NameEqualine One Step 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100041163250949 [Primary]
GS100633472000133 [Unit of Use]
GS110041163250946 [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 Number4
Public Version Date2023-07-06
Device Publish Date2016-08-10

On-Brand Devices [Equaline One Step Pregnancy Test]

00041163250949FPPL Equaline DPS +/- (ER)
00041163250932FPPL Equaline SPS +/- (ER)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.