FDA.reportPublic FDA data

Leucoscreen Plus Test Kit

Primary DI
00805360016988
Brand
Leucoscreen Plus Test Kit
Company
VITROLIFE INC.
Model
15447
Device description
Leucoscreen Plus Test Kit, 20 tests per kit
Published
2020-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00805360016988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00805360016988008053600169888053600169880805360016988

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051915038
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00805360016865Enhance Sperm Wash w/ Gentamicin152632018-04-20
00805360018494Enhance Water for Tissue Culture155222018-04-23
00805360014106Handling Pipette155302021-09-03
00805360014113Handling Pipette155312021-09-03
00805360014120Handling Pipette155322021-09-03
00805360014144Handling Pipette155332021-09-03
00805360014151Handling Pipette155342021-09-03
00805360014168Handling Pipette155352021-09-03
00805360014175Handling Pipette155362021-09-03
00805360014182Handling Pipette155372021-09-03
00805360014199Handling Pipette155382021-09-03
10805360014103Handling Pipette155302021-09-03
10805360014110Handling Pipette155312021-09-03
10805360014127Handling Pipette155322021-09-03
10805360014141Handling Pipette155332021-09-03
10805360014158Handling Pipette155342021-09-03
10805360014165Handling Pipette155352021-09-03
10805360014172Handling Pipette155362021-09-03
10805360014189Handling Pipette155372021-09-03
10805360014196Handling Pipette155382021-09-03