FDA.reportPublic FDA data

Seracult Triple Slide Fecal Occult Blood Test

Primary DI
70818087013016
Brand
Seracult Triple Slide Fecal Occult Blood Test
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
37200400
Device description
Seracult Triple Slide 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
70818087013016PrimaryGS10
10818087013014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7081808701301670818087013016
1081808701301410818087013014

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001483130
Device count
34
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30818087011618Propper Vapor Line Integrators26900921269009212026-07-16
30818087011960Propper Gas-Chex Indicator Strips26900100269001002017-10-04
70818087011623Macintosh #1 Disposable Laryngoscope Blade19924100199241002026-05-15
70818087011630Macintosh #2 Disposable Laryngoscope Blade19924200199242002026-05-15
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
30818087010918"Verline Steam Autoclave Indicator Tape 1/2"" x 14 YD - 24/pack"26814400268144002023-06-16
30818087010932"Verline Steam Autoclave Indicator Tape 3/4"" x 14 YD - 16/pack"26814500268145002023-06-16
30818087010949"Verline Steam Autoclave Indicator Tape 1"" x 14 YD - 12/pack"26814600268146002023-06-16
30818087012271"Propper 9/16"" Steri-Dot Process Indicator"36100100361001002021-09-12
30818087012325"Propper 1"" Steri-Dot Process Indicator"36100200361002002021-09-12
30818087012400"Propper 3/4"" Steam Dot Process Indicator"36400100364001002021-09-12
70818087010343"Propper Verline Indicator Tape 1/2"" x 14 YDS"26824416268244162022-10-20
70818087010367"Propper 3/4"" Steri-Dot Process Indicator Bulk Pack (110 RL/CS)"36100801361008012022-10-28
70818087010732"Propper Verline 1/2"" Steam Autoclave Tape Mini-Rolls"26814416268144162023-02-23

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