Sexual Health Test Kit STAT-PAK HIV-1/2 20 Tests CLIA Waived Sample Dependent

Key Features

SKU: CHO-60-9505-1
Condition: Factory New
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MFR: Chembio Diagnostic Ships from MFI Medical
MPN: 60-9505-1

$199.67

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Description

HIV 1/2 STAT-PAK Sample Pack is a qualitative screening test kit for the detection fo antibodies to HIV-1 and HIV-2 in serum, plasma, or whole blood
HIV 1/2 STAT-PAK delivers rapid results in 15 minutes
Minimal sample size of 5µL
Room temperature storage
Kit includes: 20 individually pouched HIV 1/2 Test Devices, 20 Disposable 5 µL Sample Loops, 1 HIV Running Buffer (3.5 mL)
Documentation included: 20 copies of Subject Information Notice, 1 Quick Reference Instructions (for CLIA Waived), 1 Product Insert
For use with control 944103 (catalog #60-9549-0)

Product Specs

Item Number	944100
Catalog Number	60-9505-1
UOM	BX
Level 1 Family Description	Lab-Waived Lab
Level 2 Category Description	Sexual Health Non-Molecular
Level 3 Group Description	HIV
Level 4 Sub-Category Description	HIV
Application	Sexual Health Test Kit
Brand	STAT-PAK
Buy American Act (BAA) Compliant	No
CLIA Classification	CLIA Waived for Whole Blood
CLIA Classified	CLIA Waived Sample Dependent
Contents 1	(20) Stat-Pak Test Devices, (20) Sample Loops, Running Buffer, Quick Reference Instructions, (20) Subject Information Notices, Product Insert
Country of Origin	Unknown
HCPCS	G0435
Is_ECAT	N
Is_GSA	Y
Is_VA	N
Manufacturer	Chembio Diagnostic
Manufacturer #	60-9505-1
McKesson #	944100
Number of Tests	20 Tests
Purchase Program Type	Standard Purchase
Reading Type	Visual Read
Sample Type	Whole Blood / Serum / Plasma Sample
Specialty	Immunoassay
Test Format	Cassette Format
Test Kit Type	Rapid
Test Name	HIV-1/2
Test Type	Antibody Test
Time to Results	15 Minute Results
Trade Agreement Act (TAA) Compliant	No
UNSPSC Code	41116144

Frequently asked questions

Does this kit provide results in a timely manner?

Yes, this professional-grade kit is designed for efficiency, delivering qualitative results in just 15 minutes.

Is the required sample size manageable for patients?

The test is highly efficient, requiring a minimal sample size of only 5µL, which helps improve the testing experience.

Can I use different types of patient samples?

The STAT-PAK HIV-1/2 kit offers excellent versatility and is compatible with three common sample types: serum, plasma, or whole blood.

Are special storage conditions required for this kit?

No, the kit is designed for convenience; it is suitable for room temperature storage, which simplifies inventory management in busy clinical settings.

Is this test classified as CLIA Waived?

Yes, the HIV-1/2 STAT-PAK is CLIA Waived for whole blood, making it suitable for use in a variety of healthcare settings.

Does the kit include everything needed to perform the tests?

Yes, each kit is self-contained and includes:

20 individually pouched test devices
20 disposable 5 µL sample loops
3.5 mL of running buffer
Required subject information notices and reference instructions.

How easy is it to interpret the final results?

The test uses a straightforward cassette-based format with a clear result window, designed for accurate and easy visual reading by professionals.

What is the primary intended use for this test?

This is a professional-grade, rapid qualitative screening tool specifically engineered for the detection of antibodies to HIV-1 and HIV-2.

Is this kit suitable for high-volume clinical environments?

Yes, the kit contains 20 tests and is designed specifically for clinical use where fast, reliable, and standardized screening is required.

Are the components designed for precise specimen collection?

Yes, the kit includes specialized disposable 5 µL sample loops, ensuring that the precise amount of specimen is collected for every test.