FDA.reportPublic FDA data

Thermo Scientific Protocol™ Parasitology System

Primary DI
00845275004953
Brand
Thermo Scientific Protocol™ Parasitology System
Company
Fisher Diagnostics
Model
23-005-28
Published
2016-09-16
Public version status
Update
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
LDYFixative, Formalin-Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDYFixative, Formalin-ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275004953PrimaryGS10
00845275006339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275004953008452750049538452750049530845275004953
00845275006339008452750063398452750063390845275006339

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixativeA covered plastic receptacle containing sodium acetate, acetic acid and/or formaldehyde (SAF) fixative solution intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation. This is a single-use device.

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
800-528-0494xx@xx.xx

Regulatory Flags#

DUNS number
183998769
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845275002751Thermo Scientific Infinity™TR254212016-09-16
00845275000504Thermo Scientific Pacific Hemostasis®1003012016-09-16
00845275000559Thermo Scientific Pacific Hemostasis®1005952016-09-16
00845275000566Thermo Scientific Pacific Hemostasis®1005962016-09-16
00845275000573Thermo Scientific Pacific Hemostasis®1005972016-09-16
00845275000580Thermo Scientific Pacific Hemostasis®1006012016-09-16
00845275000634Thermo Scientific Pacific Hemostasis®1003082016-09-16
00845275000658Thermo Scientific Pacific Hemostasis®1003122016-09-16
00845275000818Thermo Scientific Pacific Hemostasis®1005602016-09-16
00845275000832Thermo Scientific Pacific Hemostasis®1006032016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®1006062016-09-16
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers OSR611542025-11-18
00845275000405Thermo Scientific TR360262016-09-16
00845275001068Thermo Scientific 12452502016-09-16
00845275002973Thermo Scientific TR333212016-09-16
00845275005431Thermo Scientific for Beckman Coulter SYNCHRON and UnuCel SystemsA466602016-09-16
00845275004717Thermo Scientific Nerl®JDIL55222019-08-13
00845275003031Thermo Scientific Infinity™TR351212016-09-16
00845275000528Thermo Scientific Pacific Hemostasis®1003532016-09-16
00845275000535Thermo Scientific Pacific Hemostasis®1003542016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338003746Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00846338003760Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00846338003777Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00846338003784Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00673693167505EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-10-22
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00845275004939Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004946Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004960Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004984Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16