FDA.reportPublic FDA data

pHix

Primary DI
10888234000501
Brand
pHix
Company
IMMUCOR, INC.
Model
0005070
Catalog number
0005070
Device description
This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box.
Published
2016-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234000501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400050110888234000501

GMDN Terms#

Term, Definition table
TermDefinition
pH-adjusted buffer solution IVDA pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-466-8267tech_support@immucor.com

Regulatory Flags#

DUNS number
061446282
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234002291Capture LISS006690800669082022-09-03
10888234001027H.P.C. (Human Platelet Concentrate)005732000573202016-04-18
10888234002475ImmuLINK00303112024-12-05
10888234000495Red Blood Cell (RBC) Storage Solution000503600050362016-04-15
10888234001065Specimen Diluent006605200660522016-04-18
10888234001072Specimen Diluent006605300660532016-04-18
10888234001041Galileo Neo006459900645992016-04-18
10888234001584Galileo Echo008700000870002016-04-18
10888234001591CMT Plates008900000890002016-04-18
10888234002321NEO Iris006459700645972018-12-10
10888234002338Echo Lumena008699800869982018-06-01
10888234001546Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum006690200669022022-09-03
10888234001553Capture-R Select006690300669032022-09-03
10888234001560Capture-P006690400669042022-09-03
10888234001577Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum006690500669052022-09-03
10888234002307Capture-R Ready Indicator Red Cells006690700669072022-09-03
10888234002314Capture-P Indicator Red Cells006690600669062022-09-03
10888234001522Referencells006690000669002022-08-03
10888234001539Capture-R Ready-Screen 3006690100669012022-08-01
10888234002239Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent10 mL size vial / 5mL fill volume00664302022-04-22

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