FDA.report

VERSATREK 528 W/22 DRAWERS/CTRL MOD

Primary DI
00848838096327
Brand
VERSATREK 528 W/22 DRAWERS/CTRL MOD
Company
REMEL, INC.
Model
Y52822
Published
2023-07-26
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

Related Records

Product Codes

CodeName
MDBSystem, Blood Culturing

Product Code Classifications

CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848838096327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838096327008488380963278488380963270848838096327

GMDN Terms

TermDefinition
Blood culture analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism. Changes in metabolite production which indicate growth may be detected using radiometric labelled substrate uptake, infrared spectrophotometric detection of CO2, fluorometric detection of fluorescent substrate uptake, photometric detection of turbidity change and/or colorimetric detection of pH induced colour change.

Sterilization Methods

Method

Regulatory Flags

DUNS number
065769564
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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