FDA.report

Immunalysis Corporation

Primary DI
00840937107560
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
CH-233-55
Device description
Immunalysis Corporation Stop Solution (55 mL) (Alere Toxicology)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937107560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937107560008409371075608409371075600840937107560

GMDN Terms

TermDefinition
Phosphoric acid stop solution reagent IVDA dilute phosphoric acid solution intended to be used to stop enzymatic activity or further development of reactions during the final processing steps of an enzyme immunoassay method, when testing clinical laboratory specimens.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
080589004
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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