Unique device identifiers (GUDID)

PRAS Botulism Selective Medium (BSM) · AS-223

ANAEROBE SYSTEMS · AS-223 Botulism Selective Medium (BSM) is a selective and differential medium for the presumptive identification of Clo…

DI 00810048901517In Commercial DistributionJSI
Open FDA's page for this record
Has donation ID number
false
Mri safety
Labeling does not contain MRI Safety Information
Record status
Published
Is labeled as nrl
false
Is rx
false
Commercial distribution status
In Commercial Distribution
Public device record key
fd5d5a19-421e-4c81-9383-1f16bb6d9ebd
Has serial number
false
Public version date
2020-05-11
Is direct marking exempt
false
Public version number
1
Labeler duns number
021192653
Is labeled as no nrl
false
Is single use
true
Is otc
false
Version or model number
AS-223
Has manufacturing date
false
Brand name
PRAS Botulism Selective Medium (BSM)
Is combination product
false
Is kit
false
Device count in base package
4
Is pm exempt
true
Has lot or batch number
true
Catalog number
AS-223
Company name
ANAEROBE SYSTEMS
Public version status
New
Has expiration date
true
Is hct p
false
Publish date
2020-05-01
Device description

AS-223 Botulism Selective Medium (BSM) is a selective and differential medium for the presumptive identification of Clostridium botulinum from food or clinical samples. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque light yellow. 4 plates per pack.

Storage
  1. Type
    Storage Environment Temperature
    High
    Unit
    Degrees Celsius
    Value
    25
    Low
    Unit
    Degrees Celsius
    Value
    20
Sterilization
Is sterile
false
Is sterilization prior use
false
Identifiers
  1. ID
    00810048901517
    Type
    Unit of Use
    Issuing agency
    GS1
  2. ID
    00810048900176
    Type
    Primary
    Issuing agency
    GS1
Product codes
  1. Code
    JSI
    Name
    Culture Media, Selective And Differential
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Selective And Differential
    Medical specialty description
    Microbiology
    Regulation number
    866.2360
    Device class
    1
Customer contacts
  1. Phone
    1-800-443-3108
    Email
    customerservice@anaerobesystems.com
Gmdn terms
  1. Code
    58585
    Name
    Differential/selective agar culture medium IVD
    Implantable
    false
    Code status
    Active
    Definition

    An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.