Sprinter XL (model 160 samples, IFA/ELISA incl. In

Primary DI
04049016109686
Brand
Sprinter XL (model 160 samples, IFA/ELISA incl. In
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
YG 0033-0101-3
Published
2016-09-24
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
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049016109686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049016109686040490161096864049016109686

GMDN Terms

TermDefinition
Enzyme immunoassay (EIA) analyser IVD, 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 an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microtitre plates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods

Method

Regulatory Flags

DUNS number
322209263
Device count
1
DM exempt
false
Premarket exempt
true
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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