Ejaculate-TIC 1:20

GUDID 04061609000033

BIOANALYTIC GmbH, biomed. Analysentechnik

Sperm concentration indicator IVD, reagent
Primary Device ID04061609000033
NIH Device Record Keyc3234d3c-06f4-4440-97e9-50e49851eaa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEjaculate-TIC 1:20
Version Model Number003605-6005
Company DUNS327536728
Company NameBIOANALYTIC GmbH, biomed. Analysentechnik
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104061609000033 [Primary]
GS104061609000552 [Unit of Use]

FDA Product Code

JCGFluid, Diluting, Manual Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-13

Devices Manufactured by BIOANALYTIC GmbH, biomed. Analysentechnik

04061609000699 - Thrombo-TIC 1:100 pur2019-03-04
04061609000712 - Thrombo-TIC 1:25 pur2019-03-04
04061609000736 - Thrombo-TIC 1:25 pur 2019-03-04
04061609000019 - Sperm-TIC 1:202018-03-29 For microscopic counting of Sperms. (5 Tests)
04061609000026 - Sperm-TIC 1:20 plus2018-03-29 For microscopic counting of Sperms. (100 Tests)
04061609000033 - Ejaculate-TIC 1:202018-03-29
04061609000033 - Ejaculate-TIC 1:202018-03-29
04061609000040 - Ejaculate-TIC 1:20 plus2018-03-29
04061609000057 - Leuko-TIC VT2018-03-29

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