FDA.reportPublic FDA data

Ricca Chemical Company®

Primary DI
00192024068552
Brand
Ricca Chemical Company®
Company
Ricca Chemical Company, LLC
Model
6630-16
Catalog number
6630
Device description
Robert's Reagent, for the Qualitative Detection of Albumin in Urine
Published
2021-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00192024068552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192024068552001920240685521920240685520192024068552

GMDN Terms#

Term, Definition table
TermDefinition
Albumin 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 quantitative measurement of albumin in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(817)461-5601technicalservices@riccachemical.com

Regulatory Flags#

DUNS number
020335667
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
00192024031143Ricca Chemical Company®2950-3229502021-02-04
00192024031150Ricca Chemical Company®2950-1629502021-02-04
00192024068545Ricca Chemical Company®6630-3266302021-02-04
00192024049827Ricca Chemical Company LLC5260-1652602023-07-05
00192024029317Ricca Chemical Company®2780-427802021-02-04
00192024029324Ricca Chemical Company®2780-1627802021-02-04
00192024025692Ricca Chemical Company®2330-3223302021-02-04
00192024025708Ricca Chemical Company®2330-523302021-02-04
00192024025715Ricca Chemical Company®2330-123302021-02-04
00192024025722Ricca Chemical Company®2330-1623302021-02-04
00192024025746Ricca Chemical Company®2340-3223402021-02-04
00192024025753Ricca Chemical Company®2340-523402021-02-04
00192024025760Ricca Chemical Company®2340-123402021-02-04
00192024025777Ricca Chemical Company®2340-1623402021-02-04
00192024036162Ricca Chemical Company®3500-435002021-02-04
00192024036179Ricca Chemical Company®3500-3235002021-02-04
00192024036186Ricca Chemical Company®3500-1635002021-02-04
00192024068187Ricca Chemical Company®6600-466002021-02-04
00192024068194Ricca Chemical Company®6600-1666002021-02-04
00192024092304Ricca Chemical Company®8850-3288502021-02-04

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
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
03610230005057ABX PENTRA URINARY PROTEINS CPHORIBA ABX SASJIQ2016-08-23