Serodia TP-PA - 220 test kit - FUJIREBIO DIAGNOSTICS, INC.

Duns Number:079291908

Device Description: 220 test kit

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More Product Details

Catalog Number

-

Brand Name

Serodia TP-PA

Version/Model Number

1633

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

K971502

Product Code Details

Product Code

GMT

Product Code Name

Antigens, Ha, Treponema Pallidum

Device Record Status

Public Device Record Key

9d1a0292-f50a-42dd-8c66-be715dc0f95e

Public Version Date

July 15, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJIREBIO DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 5