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(BACTEC MGIT) OADC + PANTA SUPPL., 100tests, kit [BD-245124]

https://unicat.msf.org/cat/product/13422
STD ELAEMDSC113

Valid Article

Former Code(s): SLASOADC3-- ELAEMGIC113
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) OADC+ PANTA SUPPLEMENT

Reserved for TB culture programmes.

Definition

OADC growth supplement provides substance essential for the growth of mycobacteria, while PANTA antibiotic mixture reduces culture contamination.

OADC and PANTA have to be added to BBL MGIT 7 ml tubes.

Specifications

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Technical specifications

  • OADC composition: Bovine albumin, dextrose, catalase, oleic acid, polyxyethylen stearate
  • PANTA component: Polymixin B, Amphotericin B, Nalixic acid, trimethoprom and Azlocillin.

Packaging & Labelling

  • OADC: 6 vials, 15 ml each.
  • PANTA: 6 vials of lyophilized antibiotic mixture

Instructions for use

The reconstituted PANTA plus ODAC mixture should be added to MGIT 7 ml prior sample sediment inoculation.

Storage

OADC

  • OADC: On receipt, store in the dark and refrigerated between 2º C and 8º C
  • Do not freeze or overheat
  • Do not open until ready to use and minimize exposure to light.
  • Shelf life: 18 months

PANTA

  • PANTA: On receipt, keep refrigerated between 2° and 8°C.
  • Shelf life: 18 months
  • Once reconstituted, PANTA plus OADC must be stored between 2° and 8°C and used within 5 days.

Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

MSF requirements

Antibiotic and supplement mixture to be added to MGIT 7 ml tubes prior inoculation of sample sediment, for culturing and isolating of M. tuberculosis complex. Each OACD/PANTA vial is sufficient for 15-18 tests.

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