DEVICE: Sprinter XL (model 160 samples, IFA/ELISA) (04049016109716)

Download: XML | JSON

Device Identifier (DI) Information

Sprinter XL (model 160 samples, IFA/ELISA)
YG 0033-0101-6

EUROIMMUN Medizinische Labordiagnostika AG
04049016109716
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Enzyme immunoassay (EIA) analyser IVD, automated A 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.
Laboratory diluter A mains electricity (AC-powered) laboratory instrument designed to make reliable and accurate dilutions of a sample and reagent (or diluent) solutions.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 24, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE