ZYM A

Primary DI
03573026142001
Brand
ZYM A
Company
BIOMERIEUX SA
Model
70494
Device description
ZYM A is a reagent associated to API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)
Published
2020-04-10
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
JTODISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Product Code Classifications

CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03573026142001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03573026142001035730261420013573026142001

GMDN Terms

TermDefinition
Multiple Staphylococcus bacterial species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Staphylococcus bacteria or other similar gram positive, catalase positive cocci isolated by culture from a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
276816717
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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