D3 - hMPV Antigen Control Slides - DIAGNOSTIC HYBRIDS, INC.

Duns Number:117359612

Device Description: hMPV Antigen Control Slides

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More Product Details

Catalog Number

01-00070.v2

Brand Name

D3

Version/Model Number

01-00070.v2

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)

Yes

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

LJG

Product Code Name

QUALITY CONTROL SLIDES

Device Record Status

Public Device Record Key

1fdc7f2d-2633-473f-8b12-db3cf2f16f8f

Public Version Date

April 29, 2019

Public Version Number

1

DI Record Publish Date

April 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAGNOSTIC HYBRIDS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 549
2 A medical device with a moderate to high risk that requires special controls. 68