FDA.reportPublic FDA data

AdexusDx hCG Test

Primary DI
00858022006209
Brand
AdexusDx hCG Test
Company
NOWDIAGNOSTICS, INC.
Model
8001-25
Catalog number
8001-25
Device description
Box of 25 cartridges/tests
Published
2017-12-22
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
K033297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033297000ZAP HCG TEST, MODEL 8001Zbx Corporation2004-03-18JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20858022006203PackageGS140In Commercial Distribution
00858022006209PrimaryGS10
00858022006186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085802200620320858022006203
00858022006209008580220062098580220062090858022006209
00858022006186008580220061868580220061860858022006186

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-core fragment (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-core fragment human chorionic gonadotropin (beta-HCG) 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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(479) 966-4511duane.poorman@nowdx.com

Regulatory Flags#

DUNS number
079541513
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858022006018First To Know Syphilis Test8057-25-CP8057-25-CP2024-12-09
10858022006015First To Know Syphilis Test8057-25-CP8057-25-CP2024-12-09
00858022006001First To Know Syphilis Test8057-18057-12024-11-11
00858022006230AdexusDx hCG Control Set (unassayed)401.009401.0092023-02-14
00858022006193AdexusDx hCG Test8001-18001-12017-12-22
00858022006216AdexusDx hCG Test8001-508001-502017-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-04-09
00810164510105Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-02-12
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20612479280162McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
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00661392055650LSL HEALTHCARELSL Industries, LLCJHI2025-06-06
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10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-12-19
00850054026651QMedix™Diagnostic Automation, Inc.JHI2024-06-25
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10673486002409Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-01-16
10673486002379TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TESTTECO DIAGNOSTICSJHI2023-10-26
00816862023787PreviewWONDFO USA CO., LTD.JHI2023-08-03