E. coliPRO™ - E. coliPRO™ O157 Latex Kit, rapid latex - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: E. coliPRO™ O157 Latex Kit, rapid latex agglutination test for E. coli O157, 50 testsA rap E. coliPRO™ O157 Latex Kit, rapid latex agglutination test for E. coli O157, 50 testsA rapid latex agglutination test kit for the identification of the E. coli O157 serotype. So sensitive that it requires only one single colony. Uses proprietary antibodies that eliminate the possibility of cross-reactions with Escherichia hermanii and other sorbitol-negative Escherichia species. Contains both positive and negative controls. Includes reaction cards and mixing sticksEach kit contains:E. coliPRO™ O157 Latex Reagent 1 dropper vial/kitE. coliPRO™ O157 Positive Control Suspension 1 dropper vial/kitE. coliPRO™ O157 Negative Control Latex Reagent 1 dropper vial/kitLatex Test Cards 20 cards/kitMixing Sticks 75 sticks/kit

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

PL070HD

Brand Name

E. coliPRO™

Version/Model Number

PL070HD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GMZ

Product Code Name

Antigens, All Types, Escherichia Coli

Device Record Status

Public Device Record Key

31e2302a-e0dd-4b8f-b757-aa7259c2ab3e

Public Version Date

September 10, 2020

Public Version Number

1

DI Record Publish Date

September 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARDY DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 630
2 A medical device with a moderate to high risk that requires special controls. 132