ELVIS - ELVIS MWP W24/6F W/CS - DIAGNOSTIC HYBRIDS, INC.

Duns Number:117359612

Device Description: ELVIS MWP W24/6F W/CS

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More Product Details

Catalog Number

55-2406S

Brand Name

ELVIS

Version/Model Number

55-2406S

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

GQL

Product Code Name

Antisera, fluorescent, herpesvirus hominis 1,2

Device Record Status

Public Device Record Key

47946155-5ef4-4906-b77c-8b44eb428192

Public Version Date

September 07, 2018

Public Version Number

1

DI Record Publish Date

August 07, 2018

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