FDA.report

PyloriTrol

Primary DI
00847661002673
Brand
PyloriTrol
Company
BIO-RAD LABORATORIES, INC.
Model
00121
Catalog number
00121
Device description
PyloriTrol (An unassayed (human) serology control.)
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OHQMulti-analyte controls unassayed

Product Code Classifications

CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847661002673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661002673008476610026738476610026730847661002673

GMDN Terms

TermDefinition
Helicobacter pylori immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Helicobacter pylori bacteria in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)854-6737qsd.techservice@bio-rad.com

Regulatory Flags

DUNS number
051624070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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