FDA.reportPublic FDA data

Refractix™ DSP

Primary DI
00812559012522
Brand
Refractix™ DSP
Company
REICHERT, INC.
Model
13930000
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PSMRefractometer For Donor Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSMRefractometer For Donor TestingClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1701280

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1701280

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812559012522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559012522008125590125228125590125220812559012522

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
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
00812559011518Clinical Refractometers Reichert® Digital Clinic-Chek139400212025-08-12
00812559011716Phoropter VRx162412025-08-12