FDA.reportPublic FDA data

Stool preparation system SAS

Primary DI
04050598010482
Brand
Stool preparation system SAS
Company
Immundiagnostik AG
Model
K 6998SAS.20.US
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050598010482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050598010482040505980104824050598010482

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use for the sampling and containment of a small, predetermined amount of faecal matter from a primary faecal specimen, for subsequent laboratory analysis and/or other investigation. It typically consists of a specimen container (e.g., tube with a cap) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium, extraction buffer), and a sampling tool (e.g., swab, brush or spatula). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321663841
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050598163300Albumin ELISAK 63302023-06-21
04050598008540IDK® Pancreatic Elastase ELISAK 6915.20.US2023-06-21
04050598010420IDK® Pancreatic Elastase ELISAK 6915.US2023-06-21
04050598169906Chymotrypsin ActivityK 69902023-06-21
04050598000445Lysozyme ELISAK 69012023-06-21
04050598000452Lysozyme ELISAK 69022023-06-21
04050598000469Lysozyme ELISAK 69032023-06-21
04050598000872α2-Makroglobulin ELISAK 6610A2023-06-21
04050598007673IDK® sIgA ELISAK 8870.20.US2023-06-21
04050598010406Lactoferrin ELISAK 6870.US2023-06-21
04050598010413Lactoferrin ELISAK 6870.20.US2023-06-21
04050598010437ox-LDL ELISAK 7810.US2023-06-21
04050598010444ox-LDL ELISAK 7810.20.US2023-06-21
04050598010451IDK® sIgA ELISAK 8870.US2023-06-21
04050598010468IDK Extract®K 6999.US2023-06-21
04050598010475Stool preparation system SASK 6998SAS.US2023-06-21
04050598010499Retinol-binding protein RBP/RBP4 ELISAK 6110.US2023-06-21
04050598010505Retinol-binding protein RBP/RBP4 ELISAK 6110.20.US2023-06-21
04050598010512IDK Extract®K 6999.17.US2023-06-21
04050598010529IDK Extract®K 6999.20.US2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
00810185250004TherapakTherapak LLCNNK2025-08-11
00810185250042TherapakTherapak LLCNNK2025-08-11
00810185250202TherapakTherapak LLCNNK2025-08-11
00810185250349TherapakTherapak LLCNNK2025-08-11
00810185250608TherapakTherapak LLCNNK2025-08-11
00810185250646TherapakTherapak LLCNNK2025-08-11
00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027066FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027080FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30