FDA.report

Protease XXIV Kit

Primary DI
00847627012272
Brand
Protease XXIV Kit
Company
BIOCARE MEDICAL LLC
Model
PR960KG15
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847627012272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627012272008476270122728476270122720847627012272

GMDN Terms

TermDefinition
Specimen preparation enzyme reagent IVDAn enzymatic substance or reactant intended to be used alone or in combination with other IVDs for the liquefication or digestion of clinical laboratory specimens containing mucoid or clumped material in preparation for further processing.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
806617825
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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