FDA.reportPublic FDA data

alpha-Amylase EPS Pancreatic

Primary DI
04015630924882
Brand
alpha-Amylase EPS Pancreatic
Company
Roche Diagnostics GmbH
Model
5167035190
Catalog number
5167035190
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JFJCATALYTIC METHODS, AMYLASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFJCatalytic Methods, AmylaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981897000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981897000ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAERoche Diagnostic Systems, Inc.1998-08-26CJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630924882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630924882040156309248824015630924882

GMDN Terms#

Term, Definition table
TermDefinition
Total amylase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total amylase in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155612AlinityABBOTT IRELANDJFJ2025-12-19
00380740156718ARCHITECTABBOTT IRELANDJFJ2025-12-19
10673486001129α – AMYLASE LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSJFJ2023-07-20
10673486001136α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480TECO DIAGNOSTICSJFJ2023-07-20
10673486001143AMYLASE REAGENT SET (KINETIC METHOD)TECO DIAGNOSTICSJFJ2023-07-20
03610230006849Yumizen C1200 AmylaseHORIBA ABX SASJFJ2020-08-31
07613336121009a-Amylase EPS ver.2Roche Diagnostics GmbHJFJ2020-03-05
07613336121016a-Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2020-03-05
00380740161668ARCHITECTAbbott GmbHJFJ2019-11-15
00630414238357Atellica CH AMY_2Siemens Healthcare Diagnostics Inc.JFJ2019-09-03
00386100002138AMY Reagent KitMEDICA CORPORATIONJFJ2019-02-14
00380740135461AlinityAbbott GmbHJFJ2018-10-05
00628063401062Amylase AssaySEKISUI DIAGNOSTICS, LLCJFJ2018-08-09
00817274022771JAS DiagnosticsDREW SCIENTIFIC, INC.JFJ2018-07-19
00630414595641Atellica CH PAmySiemens Healthcare Diagnostics Inc.JFJ2017-12-21
05060500091705Synermed®INFRARED LABORATORY SYSTEMS LLCJFJ2017-02-28
00817274022320JAS DiagnosticsDREW SCIENTIFIC, INC.JFJ2016-10-19
00817302022964CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227CAROLINA LIQUID CHEMISTRIES CORPORATIONJFJ2016-10-17
00817274022849JAS DiagnosticsDREW SCIENTIFIC, INC.JFJ2016-10-11
00842768005404Dimension® Flex® reagent cartridge AMYSiemens Healthcare Diagnostics Inc.JFJ2016-09-24
00842768015069Dimension Vista® Flex® reagent cartridge AMYSiemens Healthcare Diagnostics Inc.JFJ2016-09-24
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase ReagentsSiemens Healthcare Diagnostics Inc.JFJ2016-09-24
00657498000489a-Amylase LiquiColor®STANBIO LABORATORY, L.P.JFJ2016-09-23
00657498001707Sirrus® Alpha-Amylase LiquiColor®STANBIO LABORATORY, L.P.JFJ2016-09-23
04015630918935Amylase EPS ver2Roche Diagnostics GmbHJFJ2016-09-20
04015630913893AMYP Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2016-09-20
04015630924875alpha-Amylase EPS ver.2Roche Diagnostics GmbHJFJ2016-09-20
04015630926848alpha-Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2016-09-20
04015630926886alpha-Amylase EPS ver.2Roche Diagnostics GmbHJFJ2016-09-20
05060500090128Synermed®INFRARED LABORATORY SYSTEMS LLCJFJ2016-09-20