FDA.reportPublic FDA data

Pointe Scientific, Inc. Toxoplasma IgM

Primary DI
00811727015167
Brand
Pointe Scientific, Inc. Toxoplasma IgM
Company
HORIBA INSTRUMENTS INCORPORATED
Model
T8002-96
Catalog number
T8002-96
Device description
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.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971672000SERAQUEST TOXOPLASMA IGMQuest Intl., Inc.1997-10-21LGD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727015167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727015167008117270151678117270151670811727015167

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
052845583
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

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05391516747479Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
00630414600123Atellica IM Toxo GSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600130Atellica IM Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600147Atellica IM Toxo MSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600154Atellica IM Toxo M QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
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04015630921485Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
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04015630940301Elecsys Toxo IgGRoche Diagnostics GmbHLGD2017-04-21
00630414208442ADVIA Centaur® Toxo MSiemens Healthcare Diagnostics Inc.LGD2016-09-24
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