FDA.reportPublic FDA data

Piccolo Kidney Check

Primary DI
EABA40000331
Brand
Piccolo Kidney Check
Company
ABAXIS, INC.
Model
400-0033
Catalog number
400-0033
Device description
The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDNUrease, Photometric, Urea Nitrogen
CGXAlkaline Picrate, Colorimetry, Creatinine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942782000PICCOLO(TM)Abaxis, Inc.1995-03-13JJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA40000331PrimaryHIBCC0
EABA40000330Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-822-2947Piccolo@abaxis.com
+1 (510) 675 6500abaxis@abaxis.com
+496155780210abaxis@abaxis.de

Regulatory Flags#

DUNS number
555503770
Device count
10
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EABA40000031Piccolo Liver Panel Plus400-0003400-00032016-09-23
EABA40000261Piccolo Hepatic Function Panel400-0026400-00262016-09-23
EABA40000271Piccolo Renal Function Panel400-0027400-00272016-09-23
EABA40000281Piccolo Comprehensive Metabolic Panel400-0028400-00282016-09-23
EABA40000291Piccolo General Chemistry 13400-0029400-00292016-09-23
EABA40000351Piccolo BioChemistry Panel Plus400-0035400-00352016-09-23
EABA40000371Piccolo MetLac 12 Panel400-0037400-00372016-09-23
EABA40000411Piccolo AmLyte 13400-0041400-00412016-09-23
EABA110000001Piccolo Xpress1100-00001100-00002016-09-23
EABA11001511Piccolo Xpress Military Deployment Kit1100-15111100-15112017-06-30
EABA40000061Piccolo General Chemistry 6400-0006400-00062016-09-23
EABA40000231Piccolo MetLyte 8 Panel400-0023400-00232016-09-23
EABA40000241Piccolo Basic Metabolic Panel400-0024400-00242016-09-23
EABA40000311Piccolo Basic Metabolic Panel Plus400-0031400-00312016-09-23
EABA40000341Piccolo MetLyte Plus CRP400-0034400-00342016-09-23
EABA40000221Piccolo Electrolyte Panel400-0022400-00222016-09-23
EABA40000251Piccolo Lipid Panel400-0025400-00252016-09-23
EABA40000301Piccolo Lipid Panel Plus400-0030400-00302016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240TECO DIAGNOSTICSCGX2026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480TECO DIAGNOSTICSCGX2026-04-30
00380740159528AlinityABBOTT IRELANDCGX2024-08-15
00380740159535ARCHITECTABBOTT IRELANDCGX2024-08-15
00850053916106IDG/SanzayIDG/SANZAY CorporationCGX2024-01-09
10673486001518Teco Diagnostics Creatinine (Kinetic or Manual Endpoint Method) Reagent SetTECO DIAGNOSTICSCGX2023-11-06
10673486001549Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480TECO DIAGNOSTICSCGX2023-11-06
10673486001556Teco Diagnostics Creatinine Reagent Set (Direct Endpoint Procedure)TECO DIAGNOSTICSCGX2023-11-06
10673486001532Teco Diagnostics Creatinine (Kinetic) Reagent SetTECO DIAGNOSTICSCGX2023-10-26
00811403011117Creatinine ReagentDiamond Diagnostics Inc.CGX2023-06-05
00817302024326CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448CAROLINA LIQUID CHEMISTRIES CORPORATIONCGX2022-08-19
00811727016119Pointe Creatinine ReagentHORIBA INSTRUMENTS INCORPORATEDCGX2021-01-30
00811727015808Pointe Creatinine for BS480HORIBA INSTRUMENTS INCORPORATEDCGX2020-05-28
03610230006955Yumizen C1200 Creatinine JafféHORIBA ABX SASCGX2020-05-06
00380740161552ARCHITECTAbbott GmbHCGX2020-03-21
00380740161569ARCHITECTAbbott GmbHCGX2020-03-21
07613336121177Creatinine Jaffe Gen.2Roche Diagnostics GmbHCGX2020-03-05
10758750031788VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CDN2019-11-13
05055273201901CREATININE (CREA)RANDOX LABORATORIES LIMITEDCGX2019-06-03
00380740135119AlinityAbbott GmbHCGX2018-08-31
00380740135102AlinityAbbott GmbHCGX2018-08-08
00852169008126ClearChem Diagnostics Inc. Creatinine (Jaffe)CLEARCHEM DIAGNOSTICS INC.CGX2018-04-30
50885380153288MEDI-VACCardinal Health 200, LLCCGX2018-04-09
50885380153295MEDI-VACCardinal Health 200, LLCCGX2018-04-09
50885380153301MEDI-VACCardinal Health 200, LLCCGX2018-04-09
00630414596457Atellica CH Crea_2Siemens Healthcare Diagnostics Inc.CGX2017-12-21
05060500091873Synermed®INFRARED LABORATORY SYSTEMS LLCCGX2017-02-28
00812137011961Creatinine Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CGX2016-10-12