N/A - Indole, DMACA Spot, for indole spot test on - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: Indole, DMACA Spot, for indole spot test on filter paper, cinnamaldehyde, 15ml dropper via Indole, DMACA Spot, for indole spot test on filter paper, cinnamaldehyde, 15ml dropper vialTo perform a rapid spot indole test on filter paper (cat. no. 28310048). 15ml dropper bottle. Not for the tube indole test, see Kovac's Indole, Z67.

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More Product Details

Catalog Number

Z65

Brand Name

N/A

Version/Model Number

Z65

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

JTO

Product Code Name

Discs, Strips And Reagents, Microorganism Differentiation

Device Record Status

Public Device Record Key

606bc553-e85a-4339-9aee-f222835dbf31

Public Version Date

June 24, 2020

Public Version Number

1

DI Record Publish Date

June 16, 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