FDA.reportPublic FDA data

Leuko-TIC 1:20 blau

Primary DI
04061609000187
Brand
Leuko-TIC 1:20 blau
Company
BIOANALYTIC GmbH, biomed. Analysentechnik
Model
004013-6010
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JCGFluid, Diluting, Manual Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCGFluid, Diluting, Manual CellHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061609000187PrimaryGS10
04061609000590Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061609000187040616090001874061609000187
04061609000590040616090005904061609000590

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
327536728
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061609000699Thrombo-TIC 1:100 pur004015-6011DMD2019-02-01
04061609000712Thrombo-TIC 1:25 pur004015-6012DMD2019-02-01
04061609000736Thrombo-TIC 1:25 pur 004015-6013DMD2019-02-01
04061609000019Sperm-TIC 1:20003604-60052018-02-13
04061609000026Sperm-TIC 1:20 plus003604-61002018-02-13
04061609000033Ejaculate-TIC 1:20003605-60052018-02-13
04061609000040Ejaculate-TIC 1:20 plus003605-61002018-02-13
04061609000057Leuko-TIC VT004005-60102018-02-06
04061609000064Leuko-TIC VT plus004005-61002018-02-06
04061609000071Leuko-TIC SF 1:100004008-60102018-02-06
04061609000088Leuko-TIC SF 1:100 plus004008-61002018-02-06
04061609000095Ery-TIC 1:200004012-00062018-02-06
04061609000101Ery-TIC 1:200 plus004012-00072018-02-06
04061609000118EryCount pur004012-01002018-02-06
04061609000125EryCount pur004012-05002018-02-06
04061609000132Ery-TIC 1:200004012-60102018-02-06
04061609000149Leuko-TIC 1:20 blau004013-00062018-02-06
04061609000156Leuko-TIC 1:20 blau plus004013-00072018-02-06
04061609000163LeukoCount blau004013-01002018-02-06
04061609000170LeukoCount blau004013-05002018-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04061609000699Thrombo-TIC 1:100 purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2019-02-01
04061609000712Thrombo-TIC 1:25 purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2019-02-01
04061609000736Thrombo-TIC 1:25 pur BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2019-02-01
04061609000019Sperm-TIC 1:20BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000026Sperm-TIC 1:20 plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000033Ejaculate-TIC 1:20BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000040Ejaculate-TIC 1:20 plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000248Reti-TICBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000255Brillant Cresyl Blue Solution IsotonicBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000262Reti-TICBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000279Eos-CountBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000286Eos-TIC 1:32BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000293Eos-TIC 1:32 plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-13
04061609000057Leuko-TIC VTBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000064Leuko-TIC VT plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000071Leuko-TIC SF 1:100BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000088Leuko-TIC SF 1:100 plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000095Ery-TIC 1:200BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000101Ery-TIC 1:200 plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000118EryCount purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000125EryCount purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000132Ery-TIC 1:200BIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000149Leuko-TIC 1:20 blauBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000156Leuko-TIC 1:20 blau plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000163LeukoCount blauBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000170LeukoCount blauBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000194Thrombo-TIC 1:100 purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000200Thrombo-TIC 1:100 pur plusBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000217ThromboCount purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06
04061609000224ThromboCount purBIOANALYTIC GmbH, biomed. AnalysentechnikJCG2018-02-06