ASI RPR Disposible Test Cards - Detection of Syphilis, 25 - 15 well - ARLINGTON SCIENTIFIC, INC.

Duns Number:785966607

Device Description: Detection of Syphilis, 25 - 15 well

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More Product Details

Catalog Number

NC-906015-25

Brand Name

ASI RPR Disposible Test Cards

Version/Model Number

NC-906015-25

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

K851504

Product Code Details

Product Code

GMP

Product Code Name

Antisera, Control For Nontreponemal Tests

Device Record Status

Public Device Record Key

8801e7a7-9590-44f7-a8b5-c5f2aa33eb20

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARLINGTON SCIENTIFIC, INC." 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. 115