FDA.reportPublic FDA data

Parasite Suspensions

Primary DI
10845357035070
Brand
Parasite Suspensions
Company
MICROBIOLOGICS INC.
Model
FP02
Catalog number
FP02
Device description
Parasite Suspensions Cryptosporidium species
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845357035070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084535703507010845357035070

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(320)253-7400techsupport@microbiologics.com

Regulatory Flags#

DUNS number
060467826
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
70845357041202QC Sets and Panels: Helix Elite™819081902020-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardHE0082HFHE0082HF2026-04-15
70845357044340QC Sets and Panels: Helix Elite™82482025-09-08
70845357044395QC Sets and Panels: Helix Elite™82672025-09-08
70845357044432QC Sets and Panels: Helix Elite™826982692026-02-10
70845357044593QC Sets and Panels: KWIK-STIK™ 2 Pack5260P5260P2026-01-27
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardHE0081NSHE0081NS2024-09-04
10845357020175KWIK-STIK™0828U0828U2020-04-30
10845357029383KWIK-STIK™01018U01018U2020-04-30
10845357020199LYFO DISK™0828L0828L2020-04-30
10845357029406LYFO DISK™01018L01018L2020-04-30
80845357044422Helix Elite Molecular StandardsGS-00012025-08-14
10845357043846Helix Elite™ Molecular Standards: Inactivated StandardHE0071NHE0071N2022-02-16
10845357043853Helix Elite™ Molecular Standards: Inactivated StandardHE0072NSHE0072NS2022-02-16
80845357044415QC Sets and Panels: Helix Elite™CL00016CL000162025-05-27
10845357043952Helix Elite™ Molecular Standards: Inactivated StandardHE0074NSHE0074NS2022-02-16
70845357041127QC Sets and Panels: Helix Elite™821482142020-04-30
10634853001364Tri-Valent™ SwabCV-01CV-012022-09-26
10634853001388Tri-Valent™ SwabTVS-01TVS-012022-09-26
10634853001395Tri-Valent™ SwabTVS-02TVS-022022-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344074369MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074376MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074383MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074390MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074362MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074379MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074386MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074393MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
06973267011369RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011376FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012366RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012373FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013349RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011345RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011352FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012342RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012359FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013332RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
05032384127993REAGENT SPOT INDOLE DMACAOXOID LIMITEDLIB2025-06-27
09555240404992SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
19555240404999SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
09555240405593SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
19555240405590SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
06973267011260Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011277Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012267Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012274Inoculating Loop 10ul flexible Typenex LP0203PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267013240Inoculating Needle Rigid perforated bag packTypenex LP0302PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011246Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011253Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13