FDA.reportPublic FDA data

Pointe Scientific, Inc. Microprotein Standard

Primary DI
00811727011923
Brand
Pointe Scientific, Inc. Microprotein Standard
Company
HORIBA INSTRUMENTS INCORPORATED
Model
P7582-STD
Catalog number
P7582-STD
Device description
Pointe Scientific, Inc. Microprotein Standard is intended for use as a microprotein standard for standardization or calibration of pyragallol red microprotein procedures.1 x 15 ml.
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
JGPLowry (Colorimetric), Total Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGPLowry (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070757000MICROPROTEIN REAGENT SETPointe Scientific, Inc.,2007-12-04JGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727011923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727011923008117270119238117270119230811727011923

GMDN Terms#

Term, Definition table
TermDefinition
Total microprotein IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total microprotein in a clinical specimen.

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971674869283BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869290BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
10758750000623VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2020-05-29
10758750000630VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2020-05-29
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalCLEARCHEM DIAGNOSTICS INC.JGP2018-06-08
00817274021897JAS DiagnosticsDREW SCIENTIFIC, INC.JGP2016-09-12
00811727011916Pointe Scientific, Inc. MicroproteinHORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
00811727012753Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
10758750000593VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2016-08-10