RealTime - Abbott RealTime HIV-1 m2000 System Combined - ABBOTT MOLECULAR INC.

Duns Number:878263359

Device Description: Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM

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More Product Details

Catalog Number

06L83-007

Brand Name

RealTime

Version/Model Number

06L83-007

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BP060002,BP060002,BP060002

Product Code Details

Product Code

MZF

Product Code Name

Test, hiv detection

Device Record Status

Public Device Record Key

9c94f53b-8869-4724-8e2d-34503fbe45e5

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

January 09, 2017

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