FDA.reportPublic FDA data

VERISURE™

Primary DI
07798375772730
Brand
VERISURE™
Company
TERRAGENE S.A.
Model
73190
Device description
VERISURE™ Bowie-Dick Test Card Kit
Published
2024-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200272000Terragene ChemdyeTerragene S.A.2020-06-30JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798375772532PackageGS11In Commercial Distribution
07798375772730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798375772532077983757725327798375772532
07798375772730077983757727307798375772730

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)783-7723ASP-Complaints@asp.com

Regulatory Flags#

DUNS number
970856911
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07798375773607BIOTRACE™731202026-03-10
07798375773591BIOTRACE™731202026-03-10
07798375772815VERISURE™732602025-06-03
07798375772853SEALSURE™732702025-06-03
07798375772570VERISURE™732602025-06-03
07798375772860SEALSURE™732702025-06-03
07798164670070Bionova®BT202025-10-16
07798164670209Bionova®BT202025-10-16
07798164673545Bionova®BT202025-10-16
07798375773539ProEdgeSM-BIOIN2025-10-16
10686864061233AssureCheck™ST00052025-10-16
10686864061240AssureCheck™ST00042025-10-16
10686864061257AssureCheck™ST10202025-10-16
00686864061267AssureCheck™ST20002025-10-16
07798164678434Bionova®KPCD224-22022-03-21
07798164678441Bionova®KPCD224-22022-03-21
07798164678472Bionova®KPCD222-22022-03-21
07798164678489Bionova®KPCD222-22022-03-21
07798164678496Bionova®KPCD220-C2022-03-21
07798164678502Bionova®KPCD220-C2022-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05