LA 1 Screening Reagent - LA 1 Screening Reagent. Simplified DRVV reagent - Siemens Healthcare Diagnostics Products GmbH

Duns Number:388240673

Device Description: LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Antico LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants

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More Product Details

Catalog Number

OQGP15

Brand Name

LA 1 Screening Reagent

Version/Model Number

10461887

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

-

Product Code Details

Product Code

GIR

Product Code Name

REAGENT, RUSSEL VIPER VENOM

Device Record Status

Public Device Record Key

83b8ae76-39df-4d0d-b4d6-300bcb5a5c28

Public Version Date

November 19, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 101