FDA.reportPublic FDA data

Clinical Refractometers Reichert® Digital Clinic-Chek

Primary DI
00812559011518
Brand
Clinical Refractometers Reichert® Digital Clinic-Chek
Company
REICHERT, INC.
Model
13940021
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JRERefractometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRERefractometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812559011518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559011518008125590115188125590115180812559011518

GMDN Terms#

Term, Definition table
TermDefinition
Clinical specimen refractometerA hand-held, battery-powered instrument intended to be used in a clinical setting, typically bedside, to measure the refractive index of a fluid clinical specimen to assess the concentration of its solutes (e.g., sugar or alcohol concentration in a urine specimen). Measurements obtained by this device can be used in the diagnosis, monitoring, and treatment of certain conditions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126650253
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812559010580PDM Digital PD Meter150202025-08-12
00812559010115Ocu-Film +2306512016-09-22
00812559012096Ocu-Film +2306532016-09-22
00812559012485" Ocu-Film® +"""2306532025-08-15
00812559012492"Ocu-Film® +"""2306512025-08-14
00812559011136UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559012454Ocu-Dot® Tonometer Probes - 100 Count163182025-08-12
00812559010238Ultramatic RX Master Phoropter11625B2025-08-12
00812559010269Ultramatic RX Master Phoropter11635B2025-08-12
00812559010290Illuminated Phoropter116362025-08-12
00812559010320Illuminated Phoropter116372025-08-12
00812559010559TF50 Trial Frame150102025-08-12
00812559010566TS75 Trial Lens150152025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, Rechargeable163062025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559011419Quebec® Manual Darkfield Colony Counter133325002025-08-12
00812559011440Quebec® Digital Darkfield Colony Counter133327002025-08-12
00812559011495Reichert® Digital USG-Chek139400192025-08-12
00812559011716Phoropter VRx162412025-08-12
00812559011730Phoropter VRx162422025-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JRE2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JRE2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JRE2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JRE2025-09-18
00812559011495Reichert® Digital USG-ChekREICHERT, INC.JRE2025-08-12
00850054026729QMedix™Diagnostic Automation, Inc.JRE2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JRE2024-06-14
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10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJRE2024-06-04
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08806141303497One+Step 10ADFI CO.,LTDJRE2023-10-16
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08806141302070CYBOW 10DFI CO.,LTDJRE2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJRE2020-03-09
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