Exact Diagnostics - Parvovirus B19 Verification Panel - EXACT DIAGNOSTICS, LLC

Duns Number:079898166

Device Description: Parvovirus B19 Verification Panel

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More Product Details

Catalog Number

B19P100

Brand Name

Exact Diagnostics

Version/Model Number

B19P100

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"

Yes

For Single-Use

Yes

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

JIT

Product Code Name

Calibrator, Secondary

Device Record Status

Public Device Record Key

a783bb75-01fe-4bfa-9dbd-2ea9f34dbc6b

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXACT DIAGNOSTICS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 30