FDA.reportPublic FDA data

6.8 Cal Solution

Primary DI
00811403017355
Brand
6.8 Cal Solution
Company
Diamond Diagnostics Inc.
Model
RD-973792D
Device description
Provide a calibration point for the pH electrodes.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403017355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403017355008114030173558114030173550811403017355

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13
00811403013326Reference ElectrodeCD-476273D2023-06-13
00811403013333Chloride ElectrodeCD-476279D2023-06-13
00811403013371Fill SolutionCD-478533D2023-06-13
00811403013388Na-K-Ca-Cl Fill SolutionCD-478535D2023-06-13
00811403013456Conditoner SolutionCD-478701D2023-06-13
00811403013463Reference SolutionCD-478822D2023-06-13
00811403013609Printer PaperCD-67252D2023-06-13
00811403013630Pump TubingCD-673705D2023-06-13
00811403014040Salt Bridge SolutionDA-D105D2023-06-13
00811403014217Quick IMT Sample DiluentDA-S635D2023-06-13
00811403014224Quick IMT Diluent CheckDA-S640D2023-06-13
00811403015504Maintenance KitHM-XEA328ASD2023-06-13

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