Detector hCG - For the qualitative detection of hCG in urine - IMMUNOSTICS COMPANY, INC

Duns Number:119214195

Device Description: For the qualitative detection of hCG in urine

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More Product Details

Catalog Number

-

Brand Name

Detector hCG

Version/Model Number

IHD/P-100

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

JHI

Product Code Name

Visual, pregnancy hCG, prescription use

Device Record Status

Public Device Record Key

7a37d3a2-7f0e-417e-8452-b5f0387be5cc

Public Version Date

October 08, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUNOSTICS COMPANY, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5