Quality Choice Early Result Pregnancy Test

GUDID 00635515970717

PLPL Quality Choice DPS Early

CHAIN DRUG MARKETING ASSOCIATION, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00635515970717
NIH Device Record Keyfabebe95-8de6-4c05-a5d6-4913809457f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuality Choice Early Result Pregnancy Test
Version Model NumberPLPL
Company DUNS011920774
Company NameCHAIN DRUG MARKETING ASSOCIATION, INC.
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

Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
Emailxx@xx.xx
Phone248-449-9300
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
GS100633472000126 [Unit of Use]
GS100635515970717 [Primary]
GS110635515970714 [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 Date2016-07-21

On-Brand Devices [Quality Choice Early Result Pregnancy Test]

00635515970717PLPL Quality Choice DPS Early
10635515956640PLPL Quality Choice SPS Early Result

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