FDA.reportPublic FDA data

Control Kit - PSA

Primary DI
00816467020167
Brand
Control Kit - PSA
Company
QUALIGEN INC.
Model
PSA Controls
Catalog number
25000003
Device description
Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US.
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003095000FASTPACK CONTROLQualigen, Inc.2000-11-29JJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816467020167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816467020167008164670201678164670201670816467020167

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.

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
00816467020112FastPack® IP hCG Diluent Kit (25)hCG Diluent250000362016-09-16
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

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Primary DI, Brand, Company table
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00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
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