FDA.reportPublic FDA data

WIZARD² Gamma Counter

Primary DI
00812589020474
Brand
WIZARD² Gamma Counter
Company
REVVITY SINGAPORE PTE. LTD.
Model
2470-0200
Catalog number
2470-0200
Device description
An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
Published
2020-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJJCounter (Beta, Gamma) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJJCounter (Beta, Gamma) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812589020474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589020474008125890204748125890204740812589020474

GMDN Terms#

Term, Definition table
TermDefinition
Radioimmunoassay analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a radiometric detection system to detect the presence of immune complexes labelled using a radioisotope, together with sample processing, data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
894632777
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
00812589020429WIZARD² Gamma Counter2470-00102470-00102020-05-14
00812589020436WIZARD² Gamma Counter2470-00202470-00202020-05-14
00812589020443WIZARD² Gamma Counter2470-00502470-00502020-05-14
00812589020450WIZARD² Gamma Counter2470-01002470-01002020-05-14
00812589020467WIZARD² Gamma Counter2470-01502470-01502020-05-14
00812589020481WIZARD² Gamma Counter2480-00102480-00102020-05-14
00812589020498WIZARD² Gamma Counter3470-00503470-00502020-05-14
00812589020504WIZARD² Gamma Counter3470-01003470-01002020-05-14
00812589020528WIZARD² Gamma Counter3470-02003470-02002020-05-14
00812589020535WIZARD² Gamma Counter3470-01503470-01502020-05-14
00812589020542PinAAcle900 Atomic Absorption SpectrometerN3160051N31600512020-05-14
00812589020559PinAAcle900 Atomic Absorption SpectrometerN3160060N31600602020-05-14
00812589020566PinAAcle900 Atomic Absorption SpectrometerN3160082N31600822020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812589020429WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020436WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020443WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020450WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020467WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020481WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020498WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020504WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020528WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14
00812589020535WIZARD² Gamma CounterREVVITY SINGAPORE PTE. LTD.JJJ2020-05-14