LABType™ SSO Class II DRB3,4,5 Typing Test - Sample - DNA typing of HLA Class I or Class II alleles. - ONE LAMBDA, INC.

Duns Number:118289289

Device Description: DNA typing of HLA Class I or Class II alleles.

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More Product Details

Catalog Number

RSSO2345S

Brand Name

LABType™ SSO Class II DRB3,4,5 Typing Test - Sample

Version/Model Number

N/A

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

MZI

Product Code Name

Test,Qualitative,For Hla,Non-Diagnostic

Device Record Status

Public Device Record Key

7a53d4f6-bd3c-424b-bc0b-b2d744783abf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ONE LAMBDA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 2
U Unclassified 370