FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740159535
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
04S9520
Catalog number
04S9520
Device description
Creatinine2 3600 Tests
Published
2024-08-15
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
CGXALKALINE PICRATE, COLORIMETRY, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740159535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740159535003807401595353807401595350380740159535

GMDN Terms#

Term, Definition table
TermDefinition
Creatinine IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414611075Atellica CH Crea3Siemens Healthcare Diagnostics Inc.CGX2026-05-08
00630414653259Atellica CH Crea3Siemens Healthcare Diagnostics Inc.CGX2026-05-08
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
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
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
00817274022337JAS DiagnosticsDREW SCIENTIFIC, INC.CGX2016-10-11
15099590010737AUBeckman Coulter, Inc.CGX2016-09-24