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(BACTEC MGIT) PZA DRUG KIT, 50 tests, kit [BD-245128]

https://unicat.msf.org/cat/product/13420
STD ELAEMDSC111

Valid Article

Former Code(s): SLASPZAD1-- ELAEMGIC111
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W02039085 - Various microbiology instruments - consumables
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(BACTEC MGIT) PZA Drug kit

Reserved for TB culture programmes.

Definition

Pyrazinamide antibiotic‌ for drug susceptibility testing of Mycobacterium tuberculosis using BACTEC MGIT 960 automated system.

Specifications

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Technical specifications

Kit contains: 2 PZA lyophilized vials and 6 PZA supplement tubes, sufficient for 50 tests

  • Antibiotic vials: white powder soluble in water
  • Supplement tubes: liquid, clear, amber coloured

Instructions for use

The Kit contains 2 vials of PZA lyophilised antibiotic and 6 vials of PZA Supplement.

PZA antibiotic must be reconstituted with 2.5 ml of sterile/deionized water before addition to PZA tubes.

Each kit is sufficient for 50 tests.

Storage

  • Keep lyophilized vials refrigerated between 2º C and 8º C
  • Once reconstituted, antibiotics are to be stored in aliquots at -20°C up to 6 months
  • Once thawed, use immediately and discard unused portion
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

MSF requirements

  • Reserved for the BACTEC MGIT 960 automated system.
  • Use only with the PZA medium tube.
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