SAFECUP III 13 PANEL

GUDID 00695684444310

GERMAINE LABORATORIES, INC

Barbiturate IVD, kit, rapid ICT, clinical
Primary Device ID00695684444310
NIH Device Record Keyb0cd7cad-d554-4d4c-8c0a-beddf5d87b20
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFECUP III 13 PANEL
Version Model Number44433
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count25
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684444310 [Unit of Use]
GS100695684444334 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-25
Device Publish Date2022-08-17

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