FDA.report

HSS 1625, Lifescan Labs USA

Primary DI
04038917932172
Brand
HSS 1625, Lifescan Labs USA
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
90.2062.057
Catalog number
90.2062.057
Published
2022-11-30
Public version status
New
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

Contact Domains

Product Codes

CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917932172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917932172040389179321724038917932172

GMDN Terms

TermDefinition
Laboratory container/microscope slide robotic transfer system IVDAn assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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