FDA.report

BD Difco™ Salmonella H Antiserum EN Complex

Primary DI
00382902227014
Brand
BD Difco™ Salmonella H Antiserum EN Complex
Company
BECTON, DICKINSON AND COMPANY
Model
222701
Catalog number
222701
Device description
BD Difco™ Salmonella H Antiserum EN Complex
Published
2016-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GRMANTISERA, ALL GROUPS, SALMONELLA SPP.

Product Code Classifications

CodeDeviceSpecialtyClass
GRMAntisera, All Groups, Salmonella Spp.Microbiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00382902227014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902227014003829022270143829022270140382902227014

GMDN Terms

TermDefinition
Multiple Salmonella species culture isolate antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria isolated by culture from a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume3Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags

DUNS number
122561087
Device count
1
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
true
No natural rubber latex
false
Sterilization required before use
false

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