FDA.reportPublic FDA data

Ricca Chemical Company®

Primary DI
00192024029317
Brand
Ricca Chemical Company®
Company
Ricca Chemical Company, LLC
Model
2780-4
Catalog number
2780
Device description
Ehrlich Aldehyde Reagent, Wallace-Diamond Formulation, for Urobilinogen Determination
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
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192024029317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192024029317001920240293171920240293170192024029317

GMDN Terms#

Term, Definition table
TermDefinition
Total bilirubin 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 total bilirubin 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
00192024068552Ricca Chemical Company®6630-1666302021-02-04
00192024049827Ricca Chemical Company LLC5260-1652602023-07-05
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

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Primary DI, Brand, Company table
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20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
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00850054026729QMedix™Diagnostic Automation, Inc.CDM2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSCDM2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-05
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08806141303497One+Step 10ADFI CO.,LTDCDM2023-10-16
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10884389181973MedlineMEDLINE INDUSTRIES, INC.CDM2022-04-13
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00192024029324Ricca Chemical Company®Ricca Chemical Company, LLCCDM2021-02-04
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10888277110403MedlineMEDLINE INDUSTRIES, INC.CDM2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCCDM2020-07-09
20885380175555CARDINAL HEALTHCardinal Health 200, LLCCDM2020-06-30
20885380175579CARDINAL HEALTHCardinal Health 200, LLCCDM2020-06-30
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08806141302070CYBOW 10DFI CO.,LTDCDM2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSCDM2020-03-09