FDA.reportPublic FDA data

FastPack® IP hCG Diluent Kit (25)

Primary DI
00816467020112
Brand
FastPack® IP hCG Diluent Kit (25)
Company
QUALIGEN INC.
Model
hCG Diluent
Catalog number
25000036
Device description
Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample.
Published
2016-09-16
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
K072264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072264000FASTPACK HCG IMMUNOASSAYQualigen, Inc.2007-12-06JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816467020112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816467020112008164670201128164670201120816467020112

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-770-6127systemsupport@qualigeninc.com

Regulatory Flags#

DUNS number
959103565
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
00816467020396FastPack® IP SystemIP System08000043-A, 08000043-AR2024-09-27
00816467020402FastPack® IP SystemIP System08000043-X22024-09-27
10816467020126FastPack® IP hCG Kit (30)hCG Immunoassay250000442016-09-16
00816467020105Calibrator Kit – hCGhCG Cal250000352016-09-16
10816467020034FastPack® Testo Kit (50)Testo Immunoassay250000092016-09-16
20816467020031FastPack® IP Testo Kit (30)Testo Immunoassay250000412016-09-16
30816467020038FastPack® IP Testo Kit (90)Testo Immunoassay250000582017-09-14
00816467020044Calibrator Kit - TestosteroneTesto Cal250000142016-09-16
00816467020136FastPack® Control KitMulti-Analyte Controls250000562016-09-16
00816467020372FastPack® Pro System Pro System08000067, 08000067-R, 08000067-X2020-08-05
00816467020006FastPack® IP SystemIP System08000043, 08000043-R, 08000043-X2016-09-16
00816467020334FastPack® IP SystemIP System08000043-C, 08000043-CR2016-09-16
10816467020386FastPack SARS-CoV-2 IgGSARS-CoV-2 IgG Immunoassay250000852020-08-05
00816467020389FastPack SARS-CoV-2 IgGSARS-CoV-2 IgG Immunoassay250000852020-08-05
10816467020010FastPack® Total PSA Kit (50)TPSA Immunoassay250000012016-09-16
20816467020017FastPack® IP Total PSA Kit (30)TPSA Immunoassay250000402016-09-16
30816467020014FastPack® IP Total PSA Kit (90)TPSA Immunoassay250000572017-09-14
00816467020020Calibrator Kit - PSATPSA Cal250000022016-09-16
00816467020075Method Verification Kit - PSATPSA Verifier250000172016-09-16
00816467020167Control Kit - PSAPSA Controls250000032016-09-16

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Primary DI, Brand, Company table
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