Equaline

GUDID 10041163502984

Equaline DPS Digital Early Blue

SPD SWISS PRECISION DIAGNOSTICS GMBH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10041163502984
NIH Device Record Key8300c846-e6ed-4269-8581-29597a712524
Commercial Distribution StatusIn Commercial Distribution
Brand NameEqualine
Version Model NumberDigital Pregnancy Test
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

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
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
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Phone1-800-899-7353
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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
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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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
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
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Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
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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
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
GS100041163502987 [Primary]
GS100633472000041 [Unit of Use]
GS110041163502984 [Package]
Contains: 00041163502987
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-27
Device Publish Date2021-04-19

On-Brand Devices [Equaline ]

10041163502984Equaline DPS Digital Early Blue
10041163502977EQUALINE DPS +/- Blue Cap
10041163502960Equaline SPS Early Result

Trademark Results [Equaline]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EQUALINE
EQUALINE
78379410 3177770 Live/Registered
SUPERVALU LICENSING LLC
2004-03-05

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