FDA.reportPublic FDA data

ROM Plus® Strip Quality Control

Primary DI
00814247020468
Brand
ROM Plus® Strip Quality Control
Company
CLINICAL INNOVATIONS, LLC
Model
ROM-QCS
Device description
ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110605000ROM PLUSClinical Innovations, LLC2011-11-23NQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814247020465PackageGS15In Commercial Distribution
20814247020462PackageGS16In Commercial Distribution
00814247020468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081424702046510814247020465
2081424702046220814247020462
00814247020468008142470204688142470204680814247020468

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic fluid leak detection device IVDAn in vitro diagnostic device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place. Do not freeze.
Storage Environment Temperature4 Degrees Celsius24 Degrees Celsius

Regulatory Flags#

DUNS number
809524291
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814247021304Panniculus Retraction KitPRS-CK-05SM2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallPRS-CK-05MD2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargePRS-CK-05LG2026-05-31
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
00814247020369traxi® Panniculus Retractor ExtenderPRS-10502016-09-01
30814247020346traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetaiPRS-05302016-09-01
30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
00814247020802traxi® Panniculus RetractorPRS-EVAL2016-09-22
00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
00814247020178Koala®IPC-5000E2016-09-01
00814247020741Goldtrace OneCNS0000082016-09-01
00814247020505Spiral Fetal Scalp ElectrodeCNS0000042016-09-01
00814247020512FSE CablesSBT-70102016-09-01
00814247020529FSE CablesSBT-70112016-09-01
00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21