Am I Pregnant?

GUDID 00722355002842

Home pregnancy test for early results

IMMUNOSTICS COMPANY, INC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00722355002842
NIH Device Record Key3156d76c-1c4d-4ed5-aec7-dcd21fb034f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAm I Pregnant?
Version Model Number5050M2-1B
Company DUNS119214195
Company NameIMMUNOSTICS COMPANY, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com
Phone+1(856)727-0008
Emailinfo@acandcdistribution.com

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
GS100722355002842 [Primary]

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 Date2017-02-21

On-Brand Devices [Am I Pregnant?]

00722355002859Home pregnancy test for early results
00722355002842Home pregnancy test for early results

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