Pregcolor Plus

GUDID 00695684893019

GERMAINE LABORATORIES, INC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00695684893019
NIH Device Record Keyeb2854bb-f9cf-44e4-b6c3-e58447fb2866
Commercial Distribution StatusIn Commercial Distribution
Brand NamePregcolor Plus
Version Model Number89301
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684893019 [Primary]

FDA Product Code

DHASystem, Test, Human Chorionic Gonadotropin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

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