FDA.reportPublic FDA data

Cystine Lactose Electrolyte Deficient (CLED) Agar

Primary DI
00860003684689
Brand
Cystine Lactose Electrolyte Deficient (CLED) Agar
Company
NEOGEN CORPORATION
Model
2
Catalog number
NCM0034E
Device description
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
Published
2020-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSHCulture Media, Non-Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003684689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003684689008600036846898600036846890860003684689

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
517-372-9200jgeyer@neogen.com

Regulatory Flags#

DUNS number
069550929
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003684696CLED Agar (Legacy 7122)0NCM02562022-04-08
00860003684603Mueller Hinton Agar II0NCM0023A2020-10-20
00860003684610Mueller Hinton Agar II0NCM0023B2020-10-20
00860003684627Mueller Hinton Agar II0NCM0023C2020-10-20
00860003684634Mueller Hinton Agar II0NCM0023E2020-10-20
00860003684641Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034A2020-10-20
00860003684658Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034B2020-10-20
00860003684665Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034C2020-10-20
00860003684672Cystine Lactose Electrolyte Deficient (CLED) Agar2NCM0034D2020-10-20

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