FDA.reportPublic FDA data

Bullseye Urine

Primary DI
M20215021
Brand
Bullseye Urine
Company
Healthlink
Model
1502
Catalog number
1502
Device description
Bullseye Urine
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSJCULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20215022PackageHIBCC12In Commercial Distribution
M20215021PrimaryHIBCC0
M20215020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mueller-Hinton agar antimicrobial susceptibility culture medium IVDA non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter100Millimeter

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-2625HLKCustomerSvc@clorox.com

Regulatory Flags#

DUNS number
079376107
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M202398012BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M202398023BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M20210951MARTIN LEWIS AGAR109510952016-09-24
M20211001MODIFIED THAYER MARTIN110011002016-09-24
M20211031MUELLER HINTON110311032016-09-24
M20211041MUELLER HINTON w 5% SB110411042016-09-24
M20211061MUELLER HINTON110611062016-09-24
M20211071MUELLER HINTON w 5% SB110711072016-09-24
M20217371JEMBEC MARTIN LEWIS173717372016-09-24
M202173811JEMBEC MOD THAYER MARTIN173817382016-09-24
M2027657ML2MARTIN LEWIS G.C. SYSTEM7-657-ML7-657-ML2016-09-24
M202V8001MARTIN LEWIS G.C. SYSTEMV800V8002016-09-24
M20234711PROSPORE AUTOCLAVE AMPULE 10/BOX347134712016-10-04

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