Quality Choice One Step Pregnancy Test

GUDID 10635515900483

FPPL Quality Choice SPS +/-

CHAIN DRUG MARKETING ASSOCIATION, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10635515900483
NIH Device Record Key0d34cdbc-9cbe-485a-ba4e-63d6bce90054
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuality Choice One Step Pregnancy Test
Version Model NumberFPPL
Company DUNS011920774
Company NameCHAIN DRUG MARKETING ASSOCIATION, INC.
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

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
GS100635515900486 [Primary]
GS110635515800127 [Package]
Contains: 00635515900486
Package: Shipping Case [6 Units]
Discontinued: 2009-06-24
Not in Commercial Distribution
GS110635515900483 [Package]
Contains: 00635515900486
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 One Step Pregnancy Test]

00635515900493FPPL Quality Choice DPS +/-
10635515900483FPPL Quality Choice SPS +/-

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