FDA.report

Immunalysis Corporation

Primary DI
00840937107348
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
GPR-A-184-1000
Device description
Immunalysis Corporation Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml)
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

Product Codes

CodeName
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937107348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937107348008409371073488409371073480840937107348

GMDN Terms

TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of 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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00840937103289Immunalysis Corporation10049-1010049-102023-10-26
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00840937111864Immunalysis Corporation647OF-0100647OF-01002023-10-25
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00840937112120SEFRIA™612OF-01002021-09-30
00840937112137SEFRIA™612OF-05002021-09-30
00840937112076Immunalysis Corporation3017-103017-102021-02-05
00840937112083Immunalysis Corporation10054-1010054-102021-02-05
00840937112090Immunalysis Corporation10053-1010053-102021-02-05
00840937112106Immunalysis Corporation10052-1010052-102021-02-05
00840937112113Immunalysis Corporation10051-1010051-102021-02-05
00840937112175Immunalysis Corporation324OF-0100 324OF-0100 2021-02-01
00840937112182Immunalysis Corporation324OF-0500 324OF-0500 2021-02-01
00840937112052QuantisalQSI-POUCHQSI-POUCH2020-10-06

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08435804522199FISH PT KITVITRO SAPPM2026-01-15
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