RealTime - Abbott RealTime CT/NG Amplification Reagent - ABBOTT MOLECULAR INC.

Duns Number:878263359

Device Description: Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps

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More Product Details

Catalog Number

8L07-50

Brand Name

RealTime

Version/Model Number

8L07-50

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

-

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

K140354

Product Code Details

Product Code

LIO

Product Code Name

DEVICE, SPECIMEN COLLECTION

Device Record Status

Public Device Record Key

a14f4a61-eb93-4850-b7ba-5dc3f35860de

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT MOLECULAR INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 339
2 A medical device with a moderate to high risk that requires special controls. 76
3 A medical device with high risk that requires premarket approval 36