FDA.reportPublic FDA data

ClearChem Diagnostics Inc. Amylase

Primary DI
00852169008041
Brand
ClearChem Diagnostics Inc. Amylase
Company
CLEARCHEM DIAGNOSTICS INC.
Model
AMY1030
Catalog number
AMY1030
Device description
In Vitro Diagnostics testing kit R1:3X60mL
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CIJSACCHAROGENIC, AMYLASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIJSaccharogenic, AmylaseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852169008041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852169008041008521690080418521690080410852169008041

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-amylase isoenzyme IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an alpha-amylase isoenzyme (e.g., salivary or pancreatic) and/or to determine its enzymatic activity in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Refrigerated
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(714)734-8041dwheat@clearchem.net

Regulatory Flags#

DUNS number
010655581
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00852169008317ClearChem Diagnostics Inc. Total BilirubinBRB2122023-01-20
00852169008324ClearChem Diagnostics Inc. Direct BilirubinBRD2102023-01-20
00852169008379ClearChem Diagnostics Inc. Vitamin D (25-OH-D) KitVTD11002023-01-20
00852169008386ClearChem Diagnostics Inc. Vitamin D (25-OH-D) SetVTD12002023-01-20
00852169008126ClearChem Diagnostics Inc. Creatinine (Jaffe)CRE1120CRE11202018-04-30
00852169008171ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)CRP1320CRP13202018-04-30
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolLDL1230LDL12302018-05-18
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalMPN2020MPN20202018-06-08
00852169008232ClearChem Diagnostics Inc. TIBC-DirectITI1160ITI11602018-05-22
00852169008270ClearChem Diagnostics Inc. MicroAlbuminMAL1010MAL10102018-05-22
00852169008287ClearChem Diagnostics Inc. Hemoglobin A-1cHGB1200HGB12002018-05-22
00852169008058ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)AST1040AST10402018-05-18
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolHDL1210HDL12102018-05-18
00852169008072ClearChem Diagnostics Inc. Carbon Dioxide (CO2)CAR1090CAR10902018-04-30
00852169008027ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)ALP1010ALP10102018-04-30
00852169008034ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)ALT1020ALT10202018-04-30
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)BUN1070BUN10702018-04-30
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CPK1110CPK11102018-04-30
00852169008096ClearChem Diagnostics Inc. Bilirubin, DirectBRD1050BRD10502018-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727016034Pointe Amylase ReagentHORIBA INSTRUMENTS INCORPORATEDCIJ2021-01-30
00811727015723Pointe Amylase on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIJ2020-05-28
00812137011879AMYLASE (CNPG3) Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIJ2016-10-12
00817439020192Amylase / BS480Medtest Dx, Inc.CIJ2016-09-27
00817439020215Amylase / BS200Medtest Dx, Inc.CIJ2016-09-27
00857969006228ACEALFA WASSERMANN, INC.CIJ2016-09-24
00015482771133SPOTCHEM™ II AmylaseARKRAY USA, INC.CIJ2016-09-23
00015482771157SPOTCHEM™ II ALPARKRAY USA, INC.CIJ2016-09-23
00015482771164SPOTCHEM™ II CreatinineARKRAY USA, INC.CIJ2016-09-23
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.CIJ2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CIJ2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CIJ2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CIJ2016-09-23
05055273200560AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200577AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200584AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200607AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200645AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200652AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200676AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
00811727010285POINTE SCIENTIFIC AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727010292POINTE SCIENTIFIC AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727010308POINTE SCIENTIFIC AMYLASEHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727010315POINTE SCIENTIFIC AMYLASEHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727012562Pointe Scientfic, Inc.HORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727012906Pointe ScientificHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727013422POINTE SCIENTIFIC AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727013835Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727014641Pointe Scientific, Inc. AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727014931Pointe Scientific, Inc. AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31