Sperm-Chex Post VC 230200

GUDID 00844509001898

A positive/negative post-vasectomy sperm count control. Contains 1 vial each of positive & negative control.

STRECK, INC.

Sperm concentration indicator IVD, control
Primary Device ID00844509001898
NIH Device Record Keye03713a5-60d8-436a-9039-0a6362e88678
Commercial Distribution StatusIn Commercial Distribution
Brand NameSperm-Chex Post VC
Version Model Number230200
Catalog Number230200
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone1-800-228-6090
Emailcustserv@streck.com

Device Dimensions

Total Volume300 Microliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509001898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRFMaterial, Quality Control, Semen Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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