IDS-iSYS CTX-I (Crosslaps) Control Set - IMMUNODIAGNOSTIC SYSTEMS LIMITED

Duns Number:494268600

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More Product Details

Catalog Number

-

Brand Name

IDS-iSYS CTX-I (Crosslaps) Control Set

Version/Model Number

IS-3030

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

Yes

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

-

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

3af3e7e4-0c6f-45eb-abae-734218db76e1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUNODIAGNOSTIC SYSTEMS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
2 A medical device with a moderate to high risk that requires special controls. 18