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FaStep™ COVID-19 IgG/IgM Rapid Test

FaStep COVID-19 Antibody Test

$130.00 – $4,160.00

Product Overview

The FaStep COVID-19 Antibody Test is a rapid lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood or serum. The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.

Description

Kit Contents
  • Twenty (20) test device strips
  • Twenty (20) disposable pipettes
  • One (1) desiccant pouch
  • One (1) bottle with buffer solution
  • One (1) coated aluminum foil for single-pouched test devices
  • One (1) package insert
  • Finger lance
  • Alcohol pad
Performance Measures
  • 90% Sensitivity
  • 100% Specificity
Features
  • Fingerstick whole blood, venous whole blood, serum, or plasma
  • 24-month shelf life
  • Simultaneous detection of IgG and IgM with control line to ensure test validity
  • Room temperature storage or refrigerated (2-30°C / 36-86°F) when not in use
  • 10-Minute Test

 

Disclaimer
In the USA, this product has not been FDA cleared or approved; but has been authorized by the FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
Tests should only be conducted by a medical professional.
Due to FDA guidelines and supply chain demands all orders for this product are non-cancellable and non-returnable.
This Item is not for resale, and you must provide a valid CLIA license number in order to purchase it.

Additional information

Weight 1 lbs
Dimensions 8.7 × 6.25 × 3 in
UOM

Case/1 – 640 tests, Kit/1 – 20 tests, Pallet – 12,800 tests

Pricing and Specifications

Shipping Specifications
Quantity Price Dimensions Weight
Kit 20 tests $130.00 8.7” x 6.25” x 3” 0.9 lbs
Case 640 tests / 32 kits $4160.00 23.75” x 20” x 13.5” 28 lbs
Pallet 12,800 tests / 640 kits / 20 cs Call (855) 360-5460 40” x 48” x 67.5” 580 lbs

Attachments and Documentation

Attachments and Documentation (Click Below)

 

Related products

FaStep™ COVID-19 IgG/IgM Rapid Test

FaStep COVID-19 Antibody Test

$130.00 – $4,160.00

Product Overview

The FaStep COVID-19 Antibody Test is a rapid lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood or serum. The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.

Description

Kit Contents
  • Twenty (20) test device strips
  • Twenty (20) disposable pipettes
  • One (1) desiccant pouch
  • One (1) bottle with buffer solution
  • One (1) coated aluminum foil for single-pouched test devices
  • One (1) package insert
  • Finger lance
  • Alcohol pad
Performance Measures
  • 90% Sensitivity
  • 100% Specificity
Features
  • Fingerstick whole blood, venous whole blood, serum, or plasma
  • 24-month shelf life
  • Simultaneous detection of IgG and IgM with control line to ensure test validity
  • Room temperature storage or refrigerated (2-30°C / 36-86°F) when not in use
  • 10-Minute Test

 

Disclaimer
In the USA, this product has not been FDA cleared or approved; but has been authorized by the FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
Tests should only be conducted by a medical professional.
Due to FDA guidelines and supply chain demands all orders for this product are non-cancellable and non-returnable.
This Item is not for resale, and you must provide a valid CLIA license number in order to purchase it.

Additional information

Weight 1 lbs
Dimensions 8.7 × 6.25 × 3 in
UOM

Case/1 – 640 tests, Kit/1 – 20 tests, Pallet – 12,800 tests

Pricing and Specifications

Shipping Specifications
Quantity Price Dimensions Weight
Kit 20 tests $130.00 8.7” x 6.25” x 3” 0.9 lbs
Case 640 tests / 32 kits $4160.00 23.75” x 20” x 13.5” 28 lbs
Pallet 12,800 tests / 640 kits / 20 cs Call (855) 360-5460 40” x 48” x 67.5” 580 lbs

Attachments and Documentation

Attachments and Documentation (Click Below)

 

Related products

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