Monobind AccuLite CA 15-3 CLIA Kit - 96 Wells - MONOBIND, INC.

Duns Number:083155515

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More Product Details

Catalog Number

5675-560A

Brand Name

Monobind AccuLite CA 15-3 CLIA Kit - 96 Wells

Version/Model Number

5675-300

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

MOI

Product Code Name

SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Device Record Status

Public Device Record Key

3b53e1c3-00fc-4cff-aeef-460c1eed70ae

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONOBIND, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 94
2 A medical device with a moderate to high risk that requires special controls. 204