FDA.report

VersaTREK

Primary DI
00848838096730
Brand
VersaTREK
Company
REMEL, INC.
Model
52822-220
Catalog number
52822-220
Device description
Y52822220 VERSATREK 528 W/22 DR/CTRL MOD 220V
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00848838096730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838096730008488380967308488380967300848838096730

GMDN Terms

TermDefinition
Microorganism identification analyser IVD, automated/semi-automatedAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens by characterizing their morphology, substrate utilization and/or biochemical reactivity, using growth detection technology which may include immunoassay, colorimetry, chromatography and/or carbon dioxide (CO2) production.

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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00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
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00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18

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