FDA.reportPublic FDA data

Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay

Primary DI
M445MCCCGDFA750
Brand
Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay
Company
MEDICAL CHEMICAL CORPORATION
Model
MCC-C/G-DFA 75
Catalog number
MCC-C/G-DFA 75
Device description
The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MHIGiardia Spp.
MHJCryptosporidium Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHIGiardia Spp.Microbiology2
MHJCryptosporidium Spp.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024113000IVD CRYPTO/GIARDIA DFAIvd Research, Inc.2003-03-05MHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M445MCCCGDFA750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen, using a direct fluorescent test (DFT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
008496861
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
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