FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS

Primary DI
00630414974187
Brand
IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS
Company
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Model
10380037
Catalog number
LSCP
Device description
IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414974187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414974187006304149741876304149741870630414974187

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-use, non-sterileA non-sterile container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
186812384
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414974194IMMULITE® 1000 Systems1000 Sample Cup Caps10385183LSCC2020-09-24
00630414947440IMMULITE® 1000 Immunoassay System10380058030006-032018-12-23

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