Noble Dip Card with AD (Urine) - AMP1000/COC300/OPI2000/PCP25/THC50(pH/OX/SG) - NOBLE MEDICAL INC

Duns Number:035967806

Device Description: AMP1000/COC300/OPI2000/PCP25/THC50(pH/OX/SG)

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More Product Details

Catalog Number

-

Brand Name

Noble Dip Card with AD (Urine)

Version/Model Number

E-NMCardA-05-18-BT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 28, 2080

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)

-

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

LCM

Product Code Name

Enzyme Immunoassay, Phencyclidine

Device Record Status

Public Device Record Key

e47e5902-681f-4156-8c38-a59d9e8c2678

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOBLE MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37