FDA.reportPublic FDA data

ScheBo® Extraction buffer

Primary DI
04260152080206
Brand
ScheBo® Extraction buffer
Company
ScheBo r. Biotech Aktiengesellschaft
Model
5x
Catalog number
02
Published
2020-08-30
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
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260152080206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260152080206042601520802064260152080206

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen extraction buffer IVDA buffered solution intended to be used for the processing and preparation of a faecal specimen for subsequent clinical testing. It is typically used for the extraction of specific target analytes present in faecal matter (e.g., calprotectin).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
326980364
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
04260152080701ScheBo® Pancreatic Elastase 1™ELISA Stool Test072020-08-30
04260152082804ScheBo Master Quick-PrepStool-Extraction System28-Quick2023-06-12

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Primary DI, Brand, Company table
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08435256719499TBS Tween 20 Buffer 10X q.s. 10LVITRO SAJCC2025-02-20
08435804515078TBS Tween 20 Buffer 10XVITRO SAJCC2025-02-20
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00860011780540Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
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00810047421047N/AScientific Device Laboratory, Inc.JCC2023-01-31
00810047421054N/AScientific Device Laboratory, Inc.JCC2023-01-31
00847627014528PBS Plus 10XBIOCARE MEDICAL LLCJCC2022-12-07
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00847627014627Automation Tween 20, 20XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014634Immunocare TBS Wash Buffer 10XBIOCARE MEDICAL LLCJCC2022-12-07
0084762701466520% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701467220% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701468920% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
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00847627014658TBS Auto Wash Buffer 40XBIOCARE MEDICAL LLCJCC2022-09-23
00816085023311Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085023328Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
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