FDA.report

Parasite Suspensions

Primary DI
10845357035100
Brand
Parasite Suspensions
Company
MICROBIOLOGICS INC.
Model
FP05
Catalog number
FP05
Device description
Parasite Suspensions Ascaris lumbricoides
Published
2020-04-30
Public version status
New
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

Contact Domains

Product Codes

CodeName
LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845357035100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084535703510010845357035100

GMDN Terms

TermDefinition
Multiple faecal parasite antigen IVD, controlA material which is used to verify the performance of an assay 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(320)253-7400techsupport@microbiologics.com

Regulatory Flags

DUNS number
060467826
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
false
No natural rubber latex
false
Sterilization required before use
false

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