FDA.reportPublic FDA data

QuickProfile™ HCG Test Strip

Primary DI
M90107RD70010
Brand
QuickProfile™ HCG Test Strip
Company
LUMIQUICK DIAGNOSTICS, INC.
Model
07RD7001
Catalog number
07RD7001
Device description
immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981770000RAPIDHCG PREGNANCY TESTRapid Diagnostics, Inc.1998-06-05JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M90107RD70011PackageHIBCC50In Commercial Distribution
M90107RD70010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length72Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
408-855-0061udi@lumiquick.com

Regulatory Flags#

DUNS number
790175165
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M90107RD7205060QuickProfile™ Drugs of Abuse Test Cup07RD7205-0607RD7205-062026-03-11
M90107RD7205110QuickProfile™ Drugs of Abuse Test Cup07RD7205-1107RD7205-112026-03-10
M90107RD7205030QuickProfile™ Drugs of Abuse Test Cup07RD7205-0307RD7205-032026-03-10
M90107RD7205040QuickProfile™ Drugs of Abuse Test Cup07RD7205-0407RD7205-042026-03-10
00855636003808QuickProfile™ Covid-19/FluA&B Antigen Combo Test71118-1T71118-1T2023-09-01
M90107RD7206120QuickProfile™ Drugs of Abuse Test Cup07RD7206-1207RD7206-122022-12-02
M90107RD7205100QuickProfile™ Drugs of Abuse Test Cup07RD7205-1007RD7205-102022-07-12
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 Test07RD7065-2207RD7065-222017-11-15
M90107RD70050QuickProfile™ Methamphetamine Test Strip07RD700507RD70052017-11-15
M90107RD70070QuickProfile™ Cocaine Test Strip07RD700707RD70072017-11-15
M90107RD70080QuickProfile™ Cocaine Test Card07RD700807RD70082017-11-15
M90107RD70090QuickProfile™ THC Test Strip07RD700907RD70092017-11-15
M90107RD70100QuickProfile™ THC Test Card07RD701007RD70102017-11-15
M90107RD70110QuickProfile™ Opiate Test Strip07RD701107RD70112017-11-15
M90107RD70120QuickProfile™ Opiate Test Card07RD701207RD70122017-11-15
M90107RD70130QuickProfile™ Amphetamine Test Strip07RD701307RD70132017-11-15
M90107RD70140QuickProfile™ Amphetamine Test Card07RD701407RD70142017-11-15
M90107RD70150QuickProfile™ Barbiturate Test Strip07RD701507RD70152017-11-15
M90107RD70160QuickProfile™ Barbiturate Test Card07RD701607RD70162017-11-15
M90107RD70170QuickProfile™ Benzodiazepine Test Strip07RD701707RD70172017-11-15

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