FDA.reportPublic FDA data

Seracult Patient Kit Fecal Occult Blood Test

Primary DI
70818087013009
Brand
Seracult Patient Kit Fecal Occult Blood Test
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
37200300
Device description
Seracult Patient Kit Fecal Occult Blood Test
Published
2019-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K834297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K834297000PROPPER SERACULTPropper Mfg. Co., Inc.1984-01-27KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70818087013009PrimaryGS10
10818087013007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7081808701300970818087013009
1081808701300710818087013007

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001483130
Device count
100
Lot or batch
true
Expiration date on label
true

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70818087011647Macintosh #3 Disposable Laryngoscope Blade19924300199243002026-05-15
70818087011814Macintosh #4 Disposable Laryngoscope Blade19924400199244002026-05-15
70818087011821Miller #0 Disposable Laryngoscope Blade19934000199340002026-05-15
70818087012040Miller #2 Disposable Laryngoscope Blade19934200199342002026-05-15
70818087012156Miller #3 Disposable Laryngoscope Blade19934300199343002026-05-15
70818087012163Miller #4 Disposable Laryngoscope Blade19934400199344002026-05-15
70818087013214Miller #1 Disposable Laryngoscope Blade19934100199341002026-05-15
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70818087010732"Propper Verline 1/2"" Steam Autoclave Tape Mini-Rolls"26814416268144162023-02-23

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