FDA.reportPublic FDA data

Select

Primary DI
03610520002919
Brand
Select
Company
BIO-RAD
Model
63727
Catalog number
63727
Device description
UriSelect 4
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
03610520002919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610520002919036105200029193610520002919

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
Device Size Text, specify0

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723techsupport.ussd-redmond@bio-rad.com

Regulatory Flags#

DUNS number
269902602
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522220526Platelia12015253120152532023-07-03
03610520002933Select63747637472016-08-16
03610520007860PLATELIA25296252962016-08-16
03610520007877PLATELIA25297252972016-08-16
03610522220519Platelia12015289120152892023-07-03
03610520010785GEENIUS92465924652023-02-03
03610520013328EVOLIS89601896012023-02-03
03610520013571PR 410091587915872023-02-03
03610520014103BIO-RAD87530875302023-02-03
03610522189380Platelia12014064120140642023-01-08
03610520002940Select63748637482023-01-05
03610520034309Select63740637402023-01-05
03610520000953Pastorex56353563532022-12-22
03610520000960Pastorex56356563562022-12-22
03610520002490Platelia62786627862022-12-22
03610520002902Select63726637262022-12-22
03610520002971Select63751637512016-08-16
03610520007853PLATELIA26211262112016-08-16
03610520013847Geenius 72461724612015-01-12
03610520013854Geenius723392015-01-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B645T0714EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0718EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0722EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0772EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0775EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B64507151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07131EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07181EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07221EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B6453B014EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P355EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P444EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T0096EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6453B0141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P3551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P4441EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645B0318EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T00961EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6452P185EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B6453P080EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17