FDA.reportPublic FDA data

ABX PENTRA URINARY PROTEINS CP

Primary DI
03610230005057
Brand
ABX PENTRA URINARY PROTEINS CP
Company
HORIBA ABX SAS
Model
1220001642
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230005057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230005057036102300050573610230005057

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
273647420
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610230004883ABX PENTRA IMMUNO II CONTROL L/H12200016222016-08-23
03610230004623ABX CLEANER (0.5L)12109030112016-08-16
03610230009932ABX Micros 6013001465762026-01-23
03610230009444Yumizen H250013001021472024-11-29
03610230009451Yumizen H250013001021482024-11-29
03610230005774ABX PENTRA MICRO-ALB CAL12200019662016-09-05
03610230005781ABX PENTRA MICRO ALB CONTROL L/H12200019672016-08-16
03610230008232ABX Pentra Micro ALB 2 Cal13000325652017-07-07
03610230005187ABX PENTRA ALBUMIN CP12200016642016-08-23
03610230005767ABX PENTRA MICRO ALBUMIN CP12200019652016-08-16
03610230008225ABX Pentra Micro ALBUMIN 2 CP13000325632017-06-27
03610230007235Yumizen C1200 Albumin U/CSF13000238712020-09-14
03610230007464Yumizen C1200 Micro Alb U/CSF Cal Normal 1300023894 2020-09-07
03610230007891Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948 2020-09-07
03610230007914Yumizen C1200 U/CSF L2 Micro Alb Control 1300023949 2020-09-07
03610230006825Yumizen C1200 Albumin13000237992020-05-06
03610230008966Yumizen P800013000333272025-07-07
03610230009611ABX Minocal530010030053001003002024-09-27
03610230008584BFTROL13000394052024-09-26
03610230009581ABX Minotrol 16530010031253001003122024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740190316ARCHITECTABBOTT IRELANDJIQ2022-05-25
00380740190781AlinityABBOTT IRELANDJIQ2022-02-28
04987481164666Autokit Micro AlbuminFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIQ2021-07-30
00192024031143Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024031150Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068545Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068552Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
03610230008621Yumizen C1200 Urinary ProteinsHORIBA ABX SASJIQ2020-09-09
00380740135201AlinityAbbott GmbHJIQ2018-08-31
00380740119416ARCHITECTAbbott GmbHJIQ2017-01-31
00380740119393ARCHITECTAbbott GmbHJIQ2016-12-31
00380740119409ARCHITECTAbbott GmbHJIQ2016-12-31
05060500090005Synermed®INFRARED LABORATORY SYSTEMS LLCJIQ2016-09-20
00380740003630ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003647ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003654ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
15099590180164IMMAGE Beckman Coulter, Inc.JIQ2016-08-24