MedTest DX Total Iron / BS480 - Total Iron, for the quantitative determination of - Medtest Dx, Inc.

Duns Number:070371210

Device Description: Total Iron, for the quantitative determination of iron in serum using the Mindray BS-480 a Total Iron, for the quantitative determination of iron in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. Size: 5 x 58ml, 5 x 12ml

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More Product Details

Catalog Number

IRO480

Brand Name

MedTest DX Total Iron / BS480

Version/Model Number

IRO480

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

K864882

Product Code Details

Product Code

JIY

Product Code Name

Photometric Method, Iron (Non-Heme)

Device Record Status

Public Device Record Key

2be3d2fd-16fb-4d64-a166-37920076153f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEST DX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 33