FDA.reportPublic FDA data

PinAAcle900 Atomic Absorption Spectrometer

Primary DI
00812589020542
Brand
PinAAcle900 Atomic Absorption Spectrometer
Company
REVVITY SINGAPORE PTE. LTD.
Model
N3160051
Catalog number
N3160051
Device description
For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
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
JXRAtomic Absorption Spectrophotometer, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXRAtomic Absorption Spectrophotometer, General UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812589020542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589020542008125890205428125890205420812589020542

GMDN Terms#

Term, Definition table
TermDefinition
Atomic absorption spectrophotometer IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used to measure the emission, absorption, or fluorescence of electromagnetic radiation by atomic particles following atomization, most commonly by flame or furnace, to determine the concentration of a chemical and/or biological marker in a clinical specimen (e.g., electrolytes, essential trace elements, or metals in body tissues/fluids that may have been used in therapy or resulted from exposure to industrial and environmental pollutants). 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 Temperature10 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
00812589020474WIZARD² Gamma Counter2470-02002470-02002020-05-14
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
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
00812589020559PinAAcle900 Atomic Absorption SpectrometerREVVITY SINGAPORE PTE. LTD.JXR2020-05-14
00812589020566PinAAcle900 Atomic Absorption SpectrometerREVVITY SINGAPORE PTE. LTD.JXR2020-05-14