FDA.reportPublic FDA data

BD BBL™ Levine EMB Agar

Primary DI
10382902212680
Brand
BD BBL™ Levine EMB Agar
Company
BECTON, DICKINSON AND COMPANY
Model
221268
Catalog number
221268
Device description
BD BBL™ Levine EMB Agar
Published
2018-05-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSICULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902212684PackageGS110Not in Commercial Distribution
10382902212680PrimaryGS10
00382902212683Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290221268430382902212684
1038290221268010382902212680
00382902212683003829022126833829022126830382902212683

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Millimeter
Outer Diameter100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
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10382902212673BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)2212672212672016-12-21
30382903836483Nexiva3836483836482026-02-17
30382903810124Insyte Autoguard3810123810122026-02-13
30382903810230Insyte Autoguard3810233810232026-02-13
30382903810247Insyte Autoguard3810243810242026-02-13
30382903810339Insyte Autoguard3810333810332026-02-13
30382903810346Insyte Autoguard3810343810342026-02-13
30382903810377Insyte Autoguard3810373810372026-02-13
30382903810445Insyte Autoguard3810443810442026-02-13
30382903810476Insyte Autoguard3810473810472026-02-13
50382903810548Insyte Autoguard3810543810542026-02-13
50382903810579Insyte Autoguard3810573810572026-02-13
30382903818335Insyte Autoguard3818333818332026-02-13
30382903818373Insyte Autoguard3818373818372026-02-13
50382903818476Insyte Autoguard3818473818472026-02-13
30382903818540Insyte Autoguard3818543818542026-02-13
50382903818575Insyte Autoguard3818573818572026-02-13
50382903818674Insyte Autoguard3818673818672026-02-13
30382903819127Insyte Autoguard3819123819122026-02-13

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