BRT Verification Samples 100-9011

GUDID EABA10090110

BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.

Bioresource Technology

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDEABA10090110
NIH Device Record Keycf51f205-0765-4085-93f0-da49787a0f7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRT Verification Samples
Version Model Number100-9011
Catalog Number100-9011
Company DUNS928908037
Company NameBioresource Technology
Device Count3
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEABA10090110 [Unit of Use]
HIBCCEABA10090111 [Primary]

FDA Product Code

OHQMulti-Analyte Controls Unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-09
Device Publish Date2021-04-01

Devices Manufactured by Bioresource Technology

EABA10090100 - BRT Liquid Assayed Chemistry Control2021-04-09 BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for t
EABA10090110 - BRT Verification Samples2021-04-09BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.
EABA10090110 - BRT Verification Samples2021-04-09 BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.
EABA10090200 - BRT Liquid Assayed Chemistry Control with CRP2021-04-09 BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for t
EABA10090210 - BRT Verification Samples with CRP2021-04-09 BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.

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