ARCHITECT - ARCHITECT LH Reagent Kit (500T) - ABBOTT IRELAND

Duns Number:989964119

Device Description: ARCHITECT LH Reagent Kit (500T)

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More Product Details

Catalog Number

02P4035

Brand Name

ARCHITECT

Version/Model Number

2P40-35

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)

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

CEP

Product Code Name

RADIOIMMUNOASSAY, LUTEINIZING HORMONE

Device Record Status

Public Device Record Key

2b43ba4f-93e7-40ec-990d-3715a5e81e53

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT IRELAND" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 110
2 A medical device with a moderate to high risk that requires special controls. 101