Pointe Scientific, Inc. Toxoplasma IgM - Pointe Scientific, Inc. Toxoplasma IgM Reagent is - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative det Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with anti-Toxoplasma gondii IgM antibody assay, must be accompanied by an anti-Toxoplasma gondii IgG antibody assay. The assay’s performance characteristics have not been established for neonatal toxoplasmosis diagnosis. This assay has not been cleared / approved by the FDA for blood / plasma donor screening. 96 tests.

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More Product Details

Catalog Number

T8002-96

Brand Name

Pointe Scientific, Inc. Toxoplasma IgM

Version/Model Number

T8002-96

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

K971672

Product Code Details

Product Code

LGD

Product Code Name

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Device Record Status

Public Device Record Key

2a26fc93-26f5-4aac-8d9d-eb25ae07f3a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POINTE SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 455
U Unclassified 2