FDA.reportPublic FDA data

BRT Verification Samples with CRP

Primary DI
EABA10090211
Brand
BRT Verification Samples with CRP
Company
Bioresource Technology
Model
100-9021
Catalog number
100-9021
Device description
BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.
Published
2021-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA10090211PrimaryHIBCC0
EABA10090210Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Regulatory Flags#

DUNS number
928908037
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EABA10090101BRT Liquid Assayed Chemistry Control100-9010100-90102021-04-01
EABA10090111BRT Verification Samples100-9011100-90112021-04-01
EABA10090201BRT Liquid Assayed Chemistry Control with CRP100-9020100-90202021-04-01
EABA10090100BRT Liquid Assayed Chemistry Control100-9010100-90102021-04-01
EABA10090110BRT Verification Samples100-9011100-90112021-04-01
EABA10090200BRT Liquid Assayed Chemistry Control with CRP100-9020100-90202021-04-01
EABA10090210BRT Verification Samples with CRP100-9021100-90212021-04-01

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